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(PRLEAP.COM)– According to a new series of reports on the European dental implant fixture and final abutment market by iData Research ( www.idataresearch.com ), a growing prevalence of local manufacturers and increasingly cost-sensitive consumer demographic is contributing to overall price deprecation and the declining market share of premium implants. Historically, premium dental implant companies have dominated the competitive landscape in Europe but have recently faced rising competition from the value and discount brands."The increasing pricing pressure in the market has led premium implant companies to levy significant discounts on their products in order to remain competitive," explains Jeffery Wong, Strategic Analyst Manager at iData Research. "Regions with a larger presence of value and discount brands have been impacted most heavily and this limiting effect on overall growth is expected to continue over the next several years."However, despite persistent price depreciation, both mature and relatively underdeveloped markets continue to generate moderate levels of unit growth, thereby mitigating the net effect on market growth. For example, the key development within the final abutment market is the rapidly increasing uptake of patient-individualized CAD/CAM solutions and focus on digital dentistry. Additionally, a growing number of local laboratories have emerged to produce and distribute CAD/CAM abutments, making them more accessible. Market growth within these segments will be driven by increased penetration in relatively underdeveloped markets, such as France and the United Kingdom.Recent improvements in manufacturing capability and product affordability have resulted in rapid adoption of the CAD/CAM abutments, which offer significant progression in aesthetics and clinical outcomes, relative to the stock and custom cast abutments. It is expected that the European market will continue to adopt CAD/CAM technology, generating consistent growth for the final abutment market.Straumann is the leading competitor in the European dental implant fixture and final abutment market. Straumann's success can be attributed to its comprehensive product portfolio comprising traditional implants and abutments, as well as offerings that include ceramic implants, full arch restorations, CAD/CAM abutments and regenerative dental biomaterials. Furthermore, Straumann has continually reinforced its leading position in the market with strategic investments in value and discount implant companies such as Neodent, Biodenta, Medentika, MegaGen and Anthogyr. Continued expansion through strategic acquisitions and partnerships will aid Straumann in maintaining its leading position in the European dental implant market. Dentsply Sirona holds the second leading position in the market, benefitting from a strong presence across all market segments. Other leading competitors include Nobel Biocare, Zimmer Biomet, CAMLOG, Sweden & Martina, Medentis, MIS Implants and BEGO among others.More on the dental implant market in Europe can be found in a series of reports published by iData Research entitled the European Market Report Suite on Dental Implant Fixtures and Final Abutments . The suite covers reports on the following markets: dental implant fixtures, final abutments, treatment planning software and surgical guides.The iData report series on dental implants covers the U.S., Japan, South Korea, Australia, China,India, Brazil, Argentina, Mexico and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players' success strategies in each market and segment. To find out more about dental implant market data or procedure data, register online or email us at info@idataresearch.net for a European Market Report Suite on Dental Implant Fixtures and Final Abutments brochure and synopsis.iData Research ( www.idataresearch.com ) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Dental Prosthetics, Dental Lasers, Dental Materials, Dental Bone Graft Substitutes, Dental Implants, Dental CAD/CAM, Dental Operatory Equipment, Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Vascular Access, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics and more.Our research empowers our clients by providing them with the necessary tools to achieve their goals and do it right the first time. We have built a reputation and earned our clients' trust based on consistent and uniquely intelligent research that allows our customers to make confident decisions and impact their businesses. A combination of market expertise and over a decade of experience has resulted in a deep understanding of the medical device industry that has inspired innovation and propelled our clients to success.


NEUCHATEL, Suíça--(BUSINESS WIRE)--A Masimo (NASDAQ: MASI) anunciou hoje as constatações de um recente estudo realizado com pacientes de baixo risco passando por cirurgia colorretal, em que os investigadores avaliaram a utilidade de monitoramento não-invasivo e contínuo com o PVi® (índice de variabilidade Pleth) da Masimo para direcionar o gerenciamento de fluidos, em comparação ao Doppler esofágico, um método invasivo. Os investigadores constataram nenhuma diferença significativa entre as duas tecnologias no fluido total médio administrado e concluíram que "PVi oferece uma alternativa completamente não-invasiva para terapia direcionada ao alvo neste grupo de pacientes".1 No estudo, Dr. Warnakulasuriya e colegas no hospital-escola de York (York Teaching Hospital), em York, Reino Unido, avaliaram o desempenho do monitoramento PVi da Masimo no direcionamento de gerenciamento de fluido, em comparação ao de uma tecnologia estabelecida, Doppler esofágico. Quarenta pacientes de baixo risco passando por cirurgia colorretal eletiva foram inscritos no estudo. Os pacientes foram atribuídos aleatoriamente a dois grupos, com cada grupo recebendo terapia de fluido direcionada por uma das duas tecnologias. Os investigadores mediram o volume absoluto de fluido administrado durante a cirurgia e o volume de fluido em 24 horas. Os investigadores constataram "nenhuma diferença significativo entre grupos PVi e Doppler esofágico no fluido total médio administrado (1286 vs 1520 ml, p=.300) ou equilíbrio médio de fluido durante cirurgia (+839 v + 1145 mL, p=.150)". PVi é uma medida de alterações dinâmicas no índice de perfusão (PI) que ocorrem durante o ciclo respiratório. Em outros estudos clínicos, o PVi tem demonstrado oferecer benefícios no monitoramento de pacientes em ventilação mecânica sob anestesia geral durante cirurgia,2,3,4,5 na UTI, com adultos e crianças,6,7 e em pacientes sépticos nas fases iniciais de choque no departamento de emergência.8 Outro estudo usou PVi como parte de terapia direcionada ao alvo para pacientes num programa enhanced recovery after surgery (ERAS) que passaram por cirurgia colorretal; o programa causou reduções significativas nos internamentos, custos, infecções no local da cirurgia, fluido administrado, bem como melhoria na satisfação do paciente.9 Num estudo no qual o PVi foi usado como o SpHb® (medição de hemoglobina não-invasiva) da Masimo, as tecnologias demonstraram reduzir a mortalidade em 30 e 90 dias.10 "Evidência clínica sobre a utilidade do PVi da Masimo continua a acumular", disse Joe Kiani, fundador e diretor executivo da Masimo. "O estudo do Dr. Warnakulasuriya oferece informações adicionais sobre os benefícios do PVi. Estamos gratos pela oportunidade de continuar a melhorar os resultados do paciente e reduzir o custo dos tratamentos com nosso monitoramento não invasivo inovador”. 1. Warnakulasuriya S et al. Comparison of esophageal Doppler and plethysmographic variability index to guide intraoperative fluid therapy for low-risk patients undergoing colorectal surgery. Journal of Clinical Anesthesia. (2016)34,600-608. 2. Cannesson M et al. Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre. Br J Anaesth. 2008;101(2):200-6. 3. Zimmermann M et al. Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major Surgery. Eur J Anaesthesiol. Junho 2010;27(6):555-61. 4. Fu Q et al. Stoke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness During Resection of Primary Retroperitoneal Tumors in Han Chinese. Biosci Trends. Fev 2012;6(1):38-43. 5. Haas S et al. Prediction of Volume Responsiveness using Pleth Variability Index in Patients Undergoing Cardiac Surgery after Cardiopulmonary Bypass. J Anesth. Out 2012;26(5):696-701. 7. Byon HJ et al. Prediction of Fluid Responsiveness in Mechanically Ventilated Children Undergoing Neurosurgery. Br J Anaesth. Abr 2013;110(4):586-91. 8. Feissel M et al. Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot Study. J Crit Care. 14 maio 2013:634-639. 9. Thiele et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. Journal of the American College of Surgeons (2015). doi: 10.1016/j.jamcollsurg.2014.12.042. 10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103. A Masimo (NASDAQ: MASI) é líder global em tecnologias inovadoras de monitoramento não invasivo. A nossa missão é melhorar os resultados do paciente e reduzir o custo dos tratamentos levando o monitoramento não invasivo a novos locais e aplicações. Em 1995, a empresa lançou o oxímetro de pulso Masimo SET® Measure-through Motion and Low Perfusion™ [Medição em Movimento com Baixa Perfusão] que, conforme demonstrado em diversos estudos, reduz consideravelmente alarmes falsos e monitora com exatidão para garantir que os alarmes sejam reais. Masimo SET® também demonstrou ajudar os médicos a reduzir a retinopatia grave da prematuridade em recém-nascidos,1 melhora na triagem de cardiopatias congênitas críticas em recém-nascidos,2 e, quando usado para o monitoramento contínuo nos centros pós-cirúrgicos, reduz as ativações e os custos de resposta rápida.3,4,5 Estima-se que o Masimo SET® seja utilizado em mais de 100 milhões de pacientes em importantes hospitais e outros ambientes de assistência médica ao redor do mundo. Em 2005, a Masimo introduziu a tecnologia rainbow® Pulse CO-Oximetry, permitindo o monitoramento não invasivo e contínuo dos componentes sanguíneos que anteriormente exigiam procedimentos exclusivamente invasivos, inclusive hemoglobina total (SpHb®), teor de oxigênio (SpOC™), carboxihemoglobina (SpCO®), metemoglobina (SpMet®) e mais recentemente o Índice de variabilidade Pleth (PVi®) e o Índice de reserva de oxigênio (ORi™), além de SpO , frequência de pulso e índice de perfusão (Pi). Estudos com SpHb demonstraram reduções nas transfusões de sangue desnecessárias*,6,7 e, quando usado com PVi, reduções do período de permanência no hospital8 e mortalidade em 30 e 90 dias.9 Em 2014, a Masimo introduziu a Root®, uma plataforma intuitiva de conectividade e monitoramento de pacientes com a interface Masimo Open Connect™ (MOC-9™), permitindo que outras empresas aprimorassem a Root com novos recursos e capacidades de medição. A Masimo também está assumindo um papel ativo de liderança em saúde eletrônica (mHealth), com produtos como o monitor de pacientes vestível Radius-7™, o oxímetro de pulso iSpO ® para smartphones e o oxímetro de pulso de ponta de dedo MightySat™. Outras informações sobre a Masimo e seus produtos estão disponíveis no site www.masimo.com. Os estudos clínicos publicados sobre os produtos da Masimo estão disponíveis em http://www.masimo.com/cpub/clinical-evidence.htm. *Decisões clínicas quanto à transfusão de glóbulos vermelhos devem ser baseadas no julgamento do médico, considerando, entre outros fatores: condição do paciente, monitoração SpHb contínua e testes de diagnóstico de laboratório, utilizando amostras de sangue. 1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO Technology. Acta Paediatr. Fev 2011;100(2):188-92. 2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338. 3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287. 5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. Jul 2016;42(7):293-302. 7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 4 fev 2015. 8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS (2015). doi: 10.1016/j.jamcollsurg.2014.12.042. 9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103. Esse comunicado de imprensa inclui declarações prospectivas conforme definido na seção 27A da Lei de Valores Mobiliários de 1933, e seção 21E da Lei de Bolsa de Valores de 1934, em conexão com a Lei de Reforma de Controvérsias de Títulos Privados de 1995. Essas declarações prospectivas incluem, entre outras, declarações associadas à potencial eficácia do PVi® da Masimo. Essas declarações prospectivas são baseadas nas expectativas atuais quanto a eventos futuros que nos afetem e estão sujeitas a riscos e incertezas, todos de difícil previsão e muitos deles além do nosso controle, os quais poderiam fazer com que nossos resultados reais divergissem adversa e substancialmente dos expressos em nossas declarações prospectivas devido a diversos fatores de risco que incluem, entre outros: riscos associados às nossas suposições quanto à capacidade de repetitividade de resultados clínicos; riscos associados à nossa convicção de que as tecnologias exclusivas de medição não invasiva da Masimo, inclusive PVi da Masimo, contribuem para a obtenção de resultados clínicos positivos e para a segurança dos pacientes; bem como outros fatores mencionados na seção "Fatores de risco" de nossos relatórios mais recentes protocolados junto à Comissão de Valores Mobiliários (Securities and Exchange Commission, SEC) dos EUA, que podem ser obtidos gratuitamente no site da SEC em www.sec.gov. Apesar de acreditarmos que as expectativas refletidas em nossas declarações prospectivas sejam razoáveis, não sabemos se nossas expectativas serão corretas. Todas as declarações prospectivas incluídas neste comunicado de imprensa são expressamente qualificadas em sua totalidade pelas declarações de advertência precedentes. Advertimos os leitores a não confiar indevidamente nessas declarações prospectivas, que dizem respeito apenas à data de hoje. Não assumimos qualquer obrigação de atualizar, corrigir ou esclarecer tais declarações ou os "Fatores de risco" descritos em nossos mais recentes relatórios protocolados junto à Comissão de Valores Mobiliários dos EUA (SEC), seja ou não como resultado de novas informações, eventos futuros ou de outra forma, exceto conforme possa ser exigido pelas leis de valores mobiliários aplicáveis. O texto no idioma original deste anúncio é a versão oficial autorizada. As traduções são fornecidas apenas como uma facilidade e devem se referir ao texto no idioma original, que é a única versão do texto que tem efeito legal.


(PRLEAP.COM)– According to a new series of reports on the India market for vascular access devices and accessories by iData Research ( www.idataresearch.com ), the Indian government has been adamant on clearing regulatory hurdles related to imports and exports of medical devices, and has set new standards around clinical trials. In addition, the Indian government runs several health insurance programs designed for high-risk patients to pay upfront cash and then get reimbursed by filing a claim. However, this process has proven inefficient and major improvements are possible if better payment mechanisms are implemented. More reform is required to bring new opportunities to invest in the healthcare market and bring profound change to the healthcare landscape in India."The Indian market is still undergoing frequent changes in terms of regulations, shaped by efforts to contain the growing healthcare budget while supporting market growth and development," explains Jeffrey Wong, Strategic Analyst Manager of iData. "In addition to healthcare reforms, the government is encouraging private capital investment to improve service quality and meet the diverse and complex needs of the public."The largest and fastest growing vascular access device segment in India is the central venous catheter (CVC) market. Growth in this market has been driven by increasing hospitalizations and rising expenditures on healthcare. The growth rate in both conventional and antimicrobial CVC unit sales have been significant and are expected to continue as these devices are the primary vascular access devices used in India.The implantable ports market will also experience high growth due to product innovations such as power-injectable implantable ports, dual lumen ports and arm ports. Multi-lumen implantable ports are selling better than previously anticipated in India. Furthermore, the use of implantable ports in India is on the rise as soaring cancer rates continue to affect the country. According to the World Health Organization, over one million newly diagnosed cases of cancer were recorded in India in 2013. The resulting increased use of chemotherapy will require implantable ports.Teleflex leads the Indian vascular access device and accessories market due to their dominance in the CVC segment and notable presence in the peripherally inserted central catheter (PICC) segment. The acquisitions of companies such as VasoNova Inc. and Nostix LLC have positioned Teleflex as an emerging force in the tip guidance space and strengthened the company's global vascular access portfolio. Poly Medicure is the second largest competitor in India and the largest local competitor in the vascular access and accessories market. The company was able to establish an early presence in the Indian market for dialysis catheters, which translated to a substantial share in the overall market. Due to its low labor costs and brand recognition, the company was able to maintain its dominance in the dialysis catheter market. Additional competitors in the Indian vascular access device market include B. Braun, Becton Dickinson, C.R. Bard, Covidien and Smiths Medical among others.More on the vascular access device market in India can be found in a series of reports published by iData Research entitled the India Market Report Suite for Vascular Access Devices and Accessories . The suite covers reports on the following markets: implantable ports, port needles, central venous catheters (CVCs), peripherally inserted central catheters (PICCs), peripheral intravenous catheters (PIVCs), and dialysis catheters.The iData report series on vascular access devices covers the U.S., Japan, South Korea, Australia, China, India and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players' success strategies in each market and segment. To find out more about vascular access device market data or procedure data, register online or email us at info@idataresearch.net for an India Market Report Suite for Vascular Access Devices and Accessories brochure and synopsis.iData Research ( www.idataresearch.com ) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. Our research empowers our clients by providing them with the necessary tools to achieve their goals and do it right the first time. iData covers research in: Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Vascular Access, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics, Dental Operatory Equipment and more.We have built a reputation and earned our clients' trust based on consistent and uniquely intelligent research that allows our customers to make confident decisions and impact their businesses. A combination of market expertise and over a decade of experience has resulted in a deep understanding of the medical device industry that has inspired innovation and propelled our clients to success.


(PRLEAP.COM)– iData Research ( www.idataresearch.com ) recently conducted a face-to-face survey for catheterization lab, structural heart and coronary stents during the 2016 Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, DC. Participants included cardiac surgeons, interventional cardiologists, interventional radiologists and general practitioners. Results have shown that clinical outcomes are the main deciding factor for respondents when choosing which brand of coronary stents to use. Respondents gave reasons for choosing a particular device, including price, availability of devices and existing relationships."This latest report is a global survey regarding demographic trends, concerns, experiences and preferences among cardiologists," explains Dr. Kamran Zamanian, CEO of iData. "Our iData team found answers to the questions posed by major cardiovascular device manufacturers regarding what they wanted to learn from the attendees of TCT 2016."Respondents came from a total of 57 countries. Each country has been subsequently categorized into six distinctive geographical regions: North America, Latin America, Europe, the Middle East, Africa and Asia. Within these regions, the United States, Brazil and Argentina represented the top three countries with the most respondents.The Global Survey on Catheterization Labs, Structural Heart and Coronary Stents by iData Research includes responses for the following questions*:*Results for each question are sorted globally and by regioniData's Global Physician Surveys are conducted by highly trained moderators with years of experience in applying iData's rigorous methodology to ensure balanced responses and to elicit keen insight from physicians, surgeons, specialists and other medical professionals. iData's Global Physician Surveys are used to garner brand awareness, product preferences, message feedback and positioning. iData's Physician Surveys allow the inclusion of a diverse range of medical professionals in broader geographical areas. They also eliminate group bias and allow for interactive one-on-one feedback as well as flexibility to expose the respondent to interactive or static media.iData Research ( www.idataresearch.com ) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Vascular Access, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics, Dental Operatory Equipment and more.


(PRLEAP.COM)According to a new series of reports on the Australia market for vascular access devices by iData Research ( www.idataresearch.com ), the use of peripherally inserted central catheters (PICCs) has grown significantly at the expense of central venous catheter (CVCs). The PIVC segment is growing rapidly as new technologies enter the market to focus on reducing infection rates and make PIVCs safer and easier to use. Nurse-led placement of PICCs has been a catalyst for the increasing adoption of PICCs which significantly lowers overall procedural cost. The combination of these factors will result in overall unit sales growth in the PICCs market.While the markets for traditional devices such as PICCs and CVCs are maturing, companies are actively investing in the development of new technological features that have increased average selling prices (ASPs) for these devices. New technologies are expected to have a significant impact on the vascular access device market. The competition in this market has spurred companies to differentiate their products in order to gain market share. This has consistently led to unique, premium-priced products."The more significant technological advancements will be in electrocardiogram (ECG) tip location," explains Dr. Kamran Zamanian, CEO of iData. "In addition, the increasing use of ultrasound has led to significant growth in the use of PICCs. Increasingly, ultrasound is being used for placement of PIVCs."Previously, implantable ports were thought to be a high potential market, owing to product innovations such as power-injectable implantable ports, dual lumen ports and arm ports. However, multi-lumen implantable ports have not sold as well as previously anticipated and the prices for power-injectable implantable ports have been decreasing dramatically. The price decreases of power-injectable implantable ports have been occurring as those devices become the standard of care in Australia and as manufacturers attempt to keep and gain market share by making their power-injectable devices more economically appealing.C. R. Bard is the leading competitor in the total Australian vascular access market. They are the strongest in the implantable port and PICC market, but also hold a significant share in the port needles market. The company has been extremely aggressive in their marketing and acquisition strategies in the vascular access market. In addition, the company continues to lead the way with new technologies, such as power-injectable devices. C. R. Bard takes advantage of the crossover between market segments and has been able to increase their presence in the rapidly growing complementary markets.Becton Dickinson is the second leading competitor, offering a wide variety of safety products. This company continues to innovate through the introduction of new products such as the Nexiva™ closed system PIVC. Additional competitors in this market include Teleflex Medical, B. Braun, Smiths Medical, Cook Medical, Medcomp, Angiodynamics, Medtronic and Baxter among others. B. Braun continues to invest in the PIVC market, with a particular focus on the safety PIVC segment.More on the vascular access device market in Australia can be found in a report suite published by iData Research entitled the Australia Market Report Suite for Vascular Access Devices and Accessories . The suite covers reports on the following markets: implantable ports, port needles, central venous catheters (CVCs), peripherally inserted central catheters (PICCs), peripheral intravenous catheters (PIVCs) and dialysis catheters.The iData report series on vascular access devices covers the U.S., Japan, South Korea, Australia, India, China, Brazil and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players' success strategies in each market and segment. To find out more about vascular access device market data or procedure data, register online or email us at info@idataresearch.net for an Australia Market Report Suite for Vascular Access Devices and Accessories brochure and synopsis.iData Research ( www.idataresearch.com ) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Vascular Access, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics, Dental Operatory Equipment and more.


News Article | February 27, 2017
Site: www.businesswire.com

NEUCHATEL, Switzerland--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today the findings of a recent study conducted on low-risk patients undergoing colorectal surgery, in which researchers assessed the utility of noninvasive and continuous Masimo PVi® (Pleth Variability Index) monitoring to guide fluid management, as compared to esophageal Doppler, an invasive method. The researchers found no significant difference between the two technologies in mean total fluid administered and concluded that “PVi offers an entirely noninvasive alternative for goal-directed therapy in this group of patients.”1 In the study, Dr. Warnakulasuriya and colleagues at York Teaching Hospital in York, United Kingdom, evaluated the performance of Masimo PVi monitoring in guiding fluid management, as compared to that of an established technology, esophageal Doppler. Forty low-risk patients undergoing elective colorectal surgery were enrolled in the study. The patients were randomly assigned to two groups, with each group having fluid therapy directed by one of the two technologies. The researchers measured the absolute volume of fluid given intraoperatively and fluid volume at 24 hours. The researchers found “no significant difference between PVi and esophageal Doppler groups in mean total fluid administered (1286 vs 1520 ml, p=.300) or mean intraoperative fluid balance (+839 v + 1145 mL, p=.150).” The researchers concluded that “amongst fit patients undergoing major colorectal surgery there was no significant difference in the volume of fluid administered when targeted by noninvasive PVi technology compared to a stroke volume maximization technique using esophageal Doppler. There was no significant difference in postoperative outcomes between the groups. Therefore, PVi offers a noninvasive, consumable free alternative for intraoperative fluid optimization in fit patients undergoing major colorectal surgery, where intraoperative goal-directed therapy is deemed a standard of care but there is no requirement for arterial cannulation.” PVi is a measure of the dynamic changes in perfusion index (PI) that occur during the respiratory cycle. In other clinical studies, PVi has been shown to provide benefits in the monitoring of mechanically-ventilated patients under general anesthesia during surgery,2,3,4,5 in the ICU in both adults and children,6,7 and in septic patients in the early stages of shock in the emergency department.8 Another study used PVi as part of goal-directed therapy for patients in an enhanced recovery after surgery (ERAS) program who underwent colorectal surgery; the program led to significant reductions in lengths of stay, costs, surgical site infections, fluid administered, as well as improvement in patient satisfaction.9 In a study in which PVi was used in conjunction with Masimo SpHb® (noninvasive hemoglobin measurement), the technologies were shown to reduce mortality at 30 and 90 days.10 “Clinical evidence for the utility of Masimo PVi continues to amass,” said Joe Kiani, Founder and CEO of Masimo. “Dr. Warnakulasuriya’s study provides additional information about the benefits of PVi. We are grateful for the opportunity we have to continue to improve patient outcomes and reduce cost of care with our innovative noninvasive monitoring.” 1. Warnakulasuriya S et al. Comparison of esophageal Doppler and plethysmographic variability index to guide intraoperative fluid therapy for low-risk patients undergoing colorectal surgery. Journal of Clinical Anesthesia. (2016)34,600-608. 2. Cannesson M et al. Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre. Br J Anaesth. 2008;101(2):200-6. 3. Zimmermann M et al. Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major Surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. 4. Fu Q et al. Stoke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness During Resection of Primary Retroperitoneal Tumors in Han Chinese. Biosci Trends. 2012 Feb;6(1):38-43. 5. Haas S et al. Prediction of Volume Responsiveness using Pleth Variability Index in Patients Undergoing Cardiac Surgery after Cardiopulmonary Bypass. J Anesth. 2012 Oct;26(5):696-701. 7. Byon HJ et al. Prediction of Fluid Responsiveness in Mechanically Ventilated Children Undergoing Neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. 8. Feissel M et al. Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot Study. J Crit Care. 2013 May 14:634-639. 9. Thiele et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. Journal of the American College of Surgeons (2015). doi: 10.1016/j.jamcollsurg.2014.12.042. 10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103. Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO , pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO ® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm. *Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples. 1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO Technology. Acta Paediatr. 2011 Feb;100(2):188-92. 2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338. 3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287. 5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302. 7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4. 8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS (2015). doi: 10.1016/j.jamcollsurg.2014.12.042. 9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103. This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVi®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo PVi, contribute to positive clinical outcomes and patient safety; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.


NEUCHÂTEL, Suisse--(BUSINESS WIRE)--Masimo (NASDAQ : MASI) a annoncé aujourd'hui les conclusions d'une étude récente menée auprès de patients à faible risque subissant une chirurgie colorectale, dans laquelle les chercheurs ont évalué l'utilité du suivi à l'aide du PVi® (Pleth Variability Index, ou indice de variabilité de la pléth) non-invasif et continu de Masimo, pour guider la gestion des fluides, par rapport au Doppler œsophagien, qui est une méthode invasive. Les chercheurs n'ont trouvé aucune différence significative entre les deux technologies en termes de quantité moyenne de fluide administré et en ont conclu que « le PVi offrait une alternative entièrement non invasive pour la thérapie ciblée dans ce groupe de patients ».1 Le PVi est une mesure des changements dynamiques de l'indice de perfusion (IP) qui se produisent pendant le cycle respiratoire. Dans d'autres études cliniques, il a été montré que le PVi offrait des avantages dans le cadre du suivi des patients ventilés mécaniquement sous anesthésie générale pendant l'intervention chirurgicale2,3,4,5, dans les unités de soins intensifs chez les adultes et les enfants6,7, et chez les patients septiques se trouvant dans les premiers stades du choc en service d'urgence.8 Une autre étude a utilisé le PVi dans le cadre de la thérapie ciblée pour des patients inclus dans un programme de récupération améliorée après chirurgie (enhanced recovery after surgery, ERAS) ayant subi une chirurgie colorectale ; le programme a entraîné des réductions significatives des durées de séjour, des coûts, des infections du site opératoire, du fluide administré, ainsi qu'une amélioration de la satisfaction des patients.9 Dans une étude dans le cadre de laquelle le PVi a été utilisé en conjonction avec la SpHb® (mesure non invasive de l'hémoglobine) de Masimo, les technologies ont montré une réduction de la mortalité à 30 et à 90 jours.10 « Les preuves cliniques montrant l'utilité du PVi de Masimo continuent de s'accumuler », a déclaré Joe Kiani, fondateur et PDG de Masimo. « L'étude du Dr Warnakulasuriya fournit des informations supplémentaires sur les avantages du PVi. Nous sommes reconnaissants de l'opportunité qui nous est offerte de continuer d'améliorer les résultats pour les patients et de réduire le coût des soins grâce à notre méthode de suivi novatrice et non invasive ». 1. Warnakulasuriya S et al. Comparison of esophageal Doppler and plethysmographic variability index to guide intraoperative fluid therapy for low-risk patients undergoing colorectal surgery. Journal of Clinical Anesthesia. (2016)34,600-608. 2. Cannesson M et al. Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre. Br J Anaesth. 2008;101(2):200-6. 3. Zimmermann M et al. Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major Surgery. Eur J Anaesthesiol. Juin 2010;27(6):555-61. 4. Fu Q et al. Stoke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness During Resection of Primary Retroperitoneal Tumors in Han Chinese. Biosci Trends. Février 2012;6(1):38-43. 5. Haas S et al. Prediction of Volume Responsiveness using Pleth Variability Index in Patients Undergoing Cardiac Surgery after Cardiopulmonary Bypass. J Anesth. Octobre 2012;26(5):696-701. 7. Byon HJ et al. Prediction of Fluid Responsiveness in Mechanically Ventilated Children Undergoing Neurosurgery. Br J Anaesth. Avril 2013;110(4):586-91. 8. Feissel M et al. Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot Study. J Crit Care. Mai 2013 14:634-639. 9. Thiele et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. Journal of the American College of Surgeons (2015). doi: 10.1016/j.jamcollsurg.2014.12.042. 10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103. Masimo (NASDAQ : MASI) est un leader mondial en technologies de surveillance non invasives novatrices. Notre mission est d’améliorer les résultats pour les patients et de réduire le coût des soins en introduisant la surveillance non invasive dans de nouveaux domaines et de nouvelles applications. En 1995, la société a lancé l'oxymétrie de pouls Masimo SET® Measure-through Motion and Low Perfusion™, qui s'est avérée capable dans plusieurs études de réduire considérablement les fausses alertes et de surveiller avec précision les alertes réelles. Il a été également démontré que Masimo SET® aidait les cliniciens à réduire la rétinopathie sévère de prématurité chez le nouveau-né,1 à améliorer le dépistage CCHD chez le nouveau-né,2 et, lorsqu'il est utilisé pour une surveillance continue dans les salles postopératoires, à réduire les activations d'intervention rapide et les coûts.3,4,5 On estime que Masimo SET® est utilisé chez plus de 100 millions de patients dans les plus grands hôpitaux et dans d'autres cadres de soins de santé à travers le monde. En 2005, Masimo a lancé la technologie de CO-oxymétrie de pouls rainbow®, pour la surveillance non invasive et continue de composants sanguins qui, auparavant, ne pouvaient être mesurés que par des procédures invasives, y compris l'hémoglobine totale (SpHb®), la teneur en oxygène (SpOC™), la carboxyhémoglobine (SpCO®), la méthémoglobine (SpMet®) et, plus récemment, l'indice de variabilité de la pléth (PVi®), l'indice de réserve d'oxygène (Oxygen Reserve Index, ORI™), ainsi que la SpO , le pouls et l'indice de perfusion (IP). Des études SpHb ont indiqué des réductions des transfusions sanguines non nécessaires*,6,7 et, utilisé avec PVi, des réductions des durées d'hospitalisation8 et de la mortalité à 30 et 90 jours.9 En 2014, Masimo a introduit Root®, une plateforme intuitive de surveillance du patient et de connectivité avec l'interface Masimo Open Connect™ (MOC-9™), permettant à d'autres entreprises d'ajouter de nouvelles fonctionnalités et de nouvelles mesures à Root. Masimo joue également un rôle actif de leader en santé mobile, avec des produits tels que le moniteur de patient portable Radius-7™, l'oxymètre de pouls pour smartphones iSpO ®et l'oxymètre de pouls du bout des doigts MightySat™. Un complément d’information sur Masimo et ses produits est disponible sur www.masimo.com. Les études cliniques publiées sur les produits Masimo sont disponibles à l'adresse http://www.masimo.com/cpub/clinical-evidence.htm. 1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO Technology. Acta Paediatr. Févr. 2011;100(2):188-92. 2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338. 3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010;112(2):282-287. 5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. Juil. 2016;42(7):293-302. 7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 4 févr. 2015. 8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS (2015). doi: 10.1016/j.jamcollsurg.2014.12.042. 9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103. Ce communiqué de presse contient des déclarations prévisionnelles, au sens de l’article 27A de loi Securities Act de 1933, de l’article 21E de la loi Securities Exchange Act de 1934 et de la loi Private Securities Litigation Reform Act de 1995. Ces déclarations prévisionnelles comprennent, notamment, des déclarations concernant l'efficacité potentielle du PVi® de Masimo. Ces déclarations prévisionnelles sont fondées sur les attentes actuelles concernant des événements futurs susceptibles de nous affecter, et sont assujetties à des risques et incertitudes, tous difficiles à prédire, souvent indépendants de notre volonté, et susceptibles de faire varier sensiblement et négativement nos résultats réels par rapport à ceux exprimés dans nos déclarations prévisionnelles, ceci en conséquence de divers facteurs de risques qui incluent, sans s'y limiter : les risques liés à nos hypothèses concernant la répétabilité des résultats cliniques ; les risques liés à notre conviction que les technologies de mesure non invasives uniques de Masimo, y compris le PVi de Masimo, contribuent à des résultats cliniques positifs et à la sécurité des patients ; ainsi que d'autres facteurs abordés dans la section « Risk Factors » (facteurs de risque) de nos rapports les plus récents déposés auprès de la Securities and Exchange Commission (« SEC »), disponibles gratuitement sur le site Web de la SEC à l'adresse www.sec.gov. Bien que nous estimions que les attentes reflétées dans nos déclarations prévisionnelles soient raisonnables, nous ignorons si ces attentes se révéleront exactes. Toutes les déclarations prévisionnelles contenues dans le présent communiqué de presse sont expressément visées dans leur intégralité par les avertissements précédents. Le lecteur est prié de ne pas se fier outre mesure à ces déclarations prévisionnelles qui ne sont valables qu’à la date d’aujourd’hui. Nous déclinons toute obligation d’actualiser, de modifier ou de clarifier ces déclarations ou les « Risk Factors » figurant dans nos rapports les plus récents déposés auprès de la SEC, que ce soit en réponse à de nouvelles informations, des événements futurs ou pour toute autre raison, sauf si les lois sur les valeurs mobilières applicables l'exigent.


Der PVI ist ein Maß für die dynamischen Veränderungen des Perfusionsindex (PI), die während des Atemzyklus auftreten. Im Rahmen weiterer klinischer Studien hat sich erwiesen, dass der PVi Vorteile bei der Überwachung mechanisch beatmeter Patienten mit sich bringt, die während einer Operation eine Allgemeinanästhesie bekommen,2,3,4,5 bei der IPS für Erwachsene wie auch für Kinder6,7 sowie bei Sepsispatienten in den frühen Schockphasen in der Notaufnahme.8 In einer weiteren Studie wurde der PVi im Rahmen einer zielorientierten Therapie bei Patienten genutzt, die an einem erweiterten postoperativen Erholungsprogramm (Recovery after Surgery, ERAS) nach einer kolorektalen Operation teilnahmen; das Programm hatte signifikante Reduzierungen der Aufenthaltsdauer, der Kosten, der Infektionen an der Operationsstelle und der verabreichten Flüssigkeit sowie eine Verbesserung der Patientenzufriedenheit zur Folge.9 Im Rahmen einer Studie, bei der der PVi in Verbindung mit Masimo SpHb® (nichtinvasive Hämoglobinmessung) genutzt wurde, erwies sich eine Reduzierung der Mortalität um 30 bzw. 90 Tage durch die Technologien. 1. Warnakulasuriya S et al. Comparison of esophageal Doppler and plethysmographic variability index to guide intraoperative fluid therapy for low-risk patients undergoing colorectal surgery. Journal of Clinical Anesthesia. (2016)34,600-608. 2. Cannesson M et al. Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre. Br J Anaesth. 2008;101(2):200-6. 3. Zimmermann M et al. Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major Surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. 4. Fu Q et al. Stoke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness During Resection of Primary Retroperitoneal Tumors in Han Chinese. Biosci Trends. 2012 Feb;6(1):38-43. 5. Haas S et al. Prediction of Volume Responsiveness using Pleth Variability Index in Patients Undergoing Cardiac Surgery after Cardiopulmonary Bypass. J Anesth. 2012 Okt;26(5):696-701. 7. Byon HJ et al. Prediction of Fluid Responsiveness in Mechanically Ventilated Children Undergoing Neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. 8. Feissel M et al. Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot Study. J Crit Care. 2013 Mai 14:634-639. 9. Thiele et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. Journal of the American College of Surgeons (2015). doi: 10.1016/j.jamcollsurg.2014.12.042. 10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103. 1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO Technology. Acta Paediatr. Februar 2011, Nr. 100(2):188-92. 2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338. 3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287. 5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302. 8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS (2015). DOI: 10.1016/j.jamcollsurg.2014.12.042. 9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103. Diese Mitteilung enthält „zukunftsgerichtete Aussagen” im Sinne von Abschnitt 27A des Securities Act von 1933 und Abschnitt 21E des Securities Exchange Act von 1934 sowie im Sinne des Private Securities Litigation Reform Act von 1995. Zu diesen zukunftsgerichteten Aussagen zählen unter anderem Aussagen zur potentiellen Effektivität des Masimo PVi®. Diese zukunftsgerichteten Aussagen gründen auf aktuellen Erwartungen zu zukünftigen, für uns relevanten Ereignissen und sind vorbehaltlich Risiken und Ungewissheiten, über die Prognosen schwierig zu treffen sind und von denen viele außerhalb unseres Einflusses liegen. Die tatsächlichen Ergebnisse könnten daher infolge diverser Risikofaktoren wesentlich und in ungünstiger Weise von den in unseren zukunftsgerichteten Aussagen gemachten Prognosen abweichen. Dazu zählen unter anderem: Risiken im Zusammenhang mit unseren Annahmen über die Wiederholbarkeit der Ergebnisse klinischer Studien; Risiken im Zusammenhang mit unserer Ansicht, dass die einzigartigen nichtinvasiven Messtechnologien von Masimo wie der Masimo PVi zu positiven klinischen Ergebnissen und zur Patientensicherheit beitragen; sowie weitere Faktoren, die im Abschnitt „Risikofaktoren” der aktuellen von uns bei der Securities and Exchange Commission („SEC”) eingereichten Berichte beschrieben sind. Diese erhalten Sie kostenlos auf der Website der SEC unter www.sec.gov. Obwohl wir der Ansicht sind, dass die in unseren zukunftsgerichteten Aussagen wiedergegebenen Erwartungen realistisch sind, wissen wir nicht, ob sich unsere Erwartungen als zutreffend erweisen werden. Sämtliche in dieser Pressemitteilung enthaltenen zukunftsgerichteten Aussagen sind in ihrer Gesamtheit ausdrücklich durch die vorausgehenden Warnhinweise eingeschränkt. Sie werden aufgefordert, sich nicht ungebührlich auf diese zukunftsgerichteten Aussagen zu verlassen, die nur für den heutigen Zeitpunkt gelten. Wir übernehmen keinerlei Verpflichtung, diese Aussagen oder die in unseren aktuellsten Berichten an die SEC enthaltenen „Risikofaktoren” zu aktualisieren, zu revidieren oder genauer darzulegen – ob aufgrund neuer Informationen, zukünftiger Ereignisse oder sonstiger Gründe, es sei denn, dies ist nach geltenden Wertpapiergesetzen erforderlich.


NEUCHATEL, Suiza--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) anunció hoy los hallazgos de un estudio reciente llevado a cabo en pacientes de bajo riesgo sometidos a cirugía colorrectal, en los que los investigadores evaluaron la utilidad del monitoreo no invasivo y continuo del índice de variabilidad pletismográfica (Pleth Variability Index, PVi®) de Masimo para guiar la gestión de fluidos, en comparación con el Doppler esofágico, un método invasivo. Los investigadores no encontraron ninguna diferencia significativa entre las dos tecnologías en el promedio total de fluidos administrados y concluyeron que “el PVi ofrece una alternativa totalmente no invasiva para la terapia dirigida a objetivos en este grupo de pacientes”.1 Los investigadores concluyeron que “entre los pacientes en forma que se someten a la cirugía colorrectal mayor no hubo diferencias significativas en el volumen de fluidos administrados cuando fue dirigido por la tecnología del PVi no invasiva en comparación con una técnica de maximización del volumen sistólico utilizando Doppler esofágico. No hubo diferencias significativas en los resultados postoperatorios entre los grupos. Por lo tanto, el PVi ofrece una alternativa libre no invasiva y consumible para la optimización intraoperatoria de fluidos en los pacientes en forma que se someten a una cirugía colorrectal mayor, en la que la terapia intraoperatoria dirigida a los objetivos se considera un estándar de atención, pero no hay un requisito para la canulación arterial”. 1. Warnakulasuriya S et al. Comparison of esophageal Doppler and plethysmographic variability index to guide intraoperative fluid therapy for low-risk patients undergoing colorectal surgery. Journal of Clinical Anesthesia. (2016)34,600-608. 2. Cannesson M et al. Pleth Variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre. Br J Anaesth. 2008;101(2):200-6. 3. Zimmermann M et al. Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically Ventilated Patients Undergoing Major Surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. 4. Fu Q et al. Stoke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness During Resection of Primary Retroperitoneal Tumors in Han Chinese. Biosci Trends. 2012 Feb;6(1):38-43. 5. Haas S et al. Prediction of Volume Responsiveness using Pleth Variability Index in Patients Undergoing Cardiac Surgery after Cardiopulmonary Bypass. J Anesth. 2012 Oct;26(5):696-701. 7. Byon HJ et al. Prediction of Fluid Responsiveness in Mechanically Ventilated Children Undergoing Neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. 8. Feissel M et al. Plethysmographic Variation Index Predicts Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock in the Emergency Department: A Pilot Study. J Crit Care. 2013 May 14:634-639. 9. Thiele et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. Journal of the American College of Surgeons (2015). doi: 10.1016/j.jamcollsurg.2014.12.042. 10. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103. Masimo (NASDAQ: MASI) es un líder mundial en innovadoras tecnologías de monitoreo no invasivas. Nuestra misión es mejorar los resultados del paciente y reducir el costo de la atención al llevar el monitoreo no invasivo a nuevos lugares y aplicaciones. En 1995, la compañía estrenó el oxímetro de pulso Masimo SET® Measure-through-Motion and Low Perfusion™, que demostró en múltiples estudios reducir significativamente las falsas alarmas y monitorear con exactitud las alarmas verdaderas. Masimo SET® también demostró ayudar a los clínicos a reducir la retinopatía severa de la prematurez en neonatos,1 mejora la detección de la cardiopatía congénita crítica (Critical Congenital Heart Disease, CCHD) en el recién nacido,2 y, cuando se lo usa para el monitoreo continuo en las salas postquirúrgicas, reduce las activaciones y costos de la respuesta rápida.3,4,5 Se estima que Masimo SET® es utilizado en más de 100 millones de pacientes en los hospitales líderes y otros entornos médicos en todo el mundo. En 2005, Masimo presentó la tecnología rainbow® Pulse CO-Oximetry, que permitió el monitoreo continuo y no invasivo de los componentes de la sangre, que, anteriormente, solo podían medirse de forma invasiva, incluidos la hemoglobina total (SpHb®), el contenido de oxígeno (SpOC™), la carboxihemoglobina (SpCO®), la metahemoglobina (SpMet®) y, más recientemente, el Índice de variabilidad pletismográfica (Pleth Variability Index, PVi®) y el Índice de reserva de oxígeno (Oxygen Reserve Index, ORi™), además del SpO , la frecuencia cardíaca y el índice de perfusión (Perfusion Index, PI). Los estudios con SpHb demostraron reducciones en transfusiones de sangre innecesarias*,6,7 y cuando se lo usa con PVi, reducciones en la duración de la hospitalización8 y la mortalidad a los 30 y 90 días.9 En 2014, Masimo introdujo Root®, una plataforma de monitoreo y conectividad intuitiva del paciente con la interfaz Masimo Open Connect™ (MOC-9™), lo que permite que otras empresas aumenten Root con nuevas funcionalidades y capacidades de medición. Masimo también está asumiendo un rol de liderazgo activo en mHealth con productos como el monitoreo portátil de pacientes Radius-7™, el pulsioxímetro para teléfonos inteligentes iSpO ® y el pulsioxímetro de dedo MightySat™. Puede encontrar más información acerca de Masimo y sus productos en www.masimo.com. Puede encontrar todos los estudios clínicos publicados sobre los productos de Masimo en http://www.masimo.com/cpub/clinical-evidence.htm. 1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO Technology. Acta Paediatr. 2011 Feb;100(2):188-92. 2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338. 3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287. 5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302. 7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4. 8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS (2015). doi: 10.1016/j.jamcollsurg.2014.12.042. 9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103. Este comunicado de prensa incluye declaraciones a futuro tal como se las define en la Sección 27A de la Ley de Títulos Valores de 1933 y la Sección 21E de la Ley de Bolsas de Valores de 1934, en relación con la Ley de Reforma de Litigios sobre Valores Privados de 1995. Estas declaraciones a futuro incluyen, entre otros, declaraciones relacionadas con la eficacia potencial del PVi® de Masimo. Estas declaraciones a futuro se basan en las expectativas actuales acerca de los eventos futuros que nos afectan y están sujetas a riesgos e incertidumbres difíciles de predecir, muchas de ellas fuera de nuestro control, y que podrían provocar que los resultados reales difieran materialmente y de modo adverso de lo expresado en nuestras declaraciones a futuro, como resultado de varios factores de riesgo que incluyen, entre otros: riesgos relacionados con nuestros supuestos acerca de la repetibilidad de los resultados clínicos; riesgos relacionados con nuestra creencia de que las tecnologías de medición no invasivas únicas de Masimo, incluido el PVi de Masimo, contribuyen a los resultados clínicos positivos y a la seguridad del paciente; así como otros factores analizados en la sección “Factores de Riesgo” de nuestros informes más recientes presentados ante la Comisión de Bolsa y Valores (Securities and Exchange Commission, SEC), disponibles de forma gratuita en el sitio web de la SEC en www.sec.gov. Aun cuando creemos que las expectativas reflejadas en nuestras declaraciones a futuro son razonables, no sabemos si nuestras expectativas resultarán correctas. Todas las declaraciones a futuro incluidas en este comunicado de prensa están expresamente calificadas en su totalidad por las anteriores declaraciones cautelares. Se advierte a los lectores no confiar indebidamente en estas declaraciones a futuro, las cuales solo afirman lo dicho al día de la fecha. No asumimos ninguna obligación para actualizar, enmendar o aclarar estas declaraciones o los “Factores de riesgo” contenidos en nuestros informes más recientes presentados ante la SEC, ya sea como resultado de nueva información, eventos futuros u otros o de lo contrario, excepto cuando lo exijan las leyes de títulos valores aplicables.


World's first annuloplasty system for mitral and tricuspid repair incorporating proprietary PolyCor™ and MyoLast™ technologies. NEWTOWN, Pennsylvania, March 1, 2017 /PRNewswire/ -- Micro Interventional Devices, Inc.™ (MID), announced today that it has successfully completed the second clinical case with its proprietary MIA™ technology for percutaneous mitral and tricuspid repair. This is the second successful clinical procedure and the second patient enrolled in the company's STTAR clinical study.  STTAR, the Study of Transcatheter Tricuspid Annular Repair, is a multi center safety and performance study being conducted in Europe. The patient was a 60-year-old man with severe mitral and moderate tricuspid regurgitation.  Eight MIA implants were deployed into the patient's tricuspid annulus in a 270-degree partial ring pattern concomitant with mitral valve repair.  The MIA deployments took 14 minutes to complete and resulted in a 48% acute reduction in annular area.  The annular reduction is achieved without sutures or other intervention. ­­ The first two procedures were performed by Professor Kestutis Rucinskas, MD, Chief of Cardiac Surgery, and Professor Audrius Aidietis, MD, Chief of Cardiology and Angiology, at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania.  As with the first case, there were no intraoperative complications or adverse events observed or reported and post-procedural patient recovery has been uneventful. The first patient, treated on December 6th, 2016, has now been followed to 30 days with no observed or reported adverse events.  The reduction in annular area observed at hospital discharge has been maintained at 30-day follow-up. "On Friday, February 3rd, we successfully deployed eight MIA implants into the patient's tricuspid annulus.  It was impressive that the clinicians only took 14 minutes to deploy the technology," Willard Hennemann, PhD, MID's Chief Science Officer, commented.  "Prior to deployment of the MIA implants the intraoperative saline injection leak test demonstrated a lack of leaflet coaptation.  After deployment of the MIA implants the saline injection leak test revealed full leaflet coaptation and a competent valve.  The acute 48% reduction in valve area observed was comparable to that achieved with the current surgical standard of care.  This reduction was maintained at hospital discharge." The MIA implant is made from the proprietary PolyCorTM anchors bonded to the proprietary, self-tensioning, implantable elastomer called MyoLastTM.  This is the world's first low mass polymeric implant designed specifically to comply with normal physiological valvular function.  The MIA implant is specifically engineered to plicate and comply with cardiac soft-tissue once deployed. "Enrolling patients in the first arm of the STTAR Study has demonstrated the feasibility of the procedure and the capability of the MIA implant to significantly reduce annular dimensions," said Michael Whitman, MID's Founder, President & CEO.  "These initial results are extremely encouraging and support our thesis that MIA is safe, simple, and secure.  We look forward to continued enrollment and further favorable results." There are approximately 2.3 million patients worldwide who are not currently being treated for mitral and tricuspid regurgitation because most candidates are not eligible for surgery, today's standard of care.1 The major advantage of MIA is its potential to address this large, underserved patient population by enabling percutaneous valve repair procedures. MID is the world leader in percutaneous transcatheter compliant fixation technology addressing unmet needs in structural heart disease. Sources: 1   Internal Estimates Based off of References on File

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