News Article | May 27, 2017
„Ein drahtloses System, das es Klinikern ermöglicht, die vollen Programmierungsfähigkeiten von IPGs zu haben, und das alles in einem Gerät, das injiziert werden kann, repräsentiert einen Paradigmenwechselim Feld der Optionen, das Beste zu bieten, was die Anpassung für Patienten an die Verwaltung ihrer Schmerzprofile betrifft“, sagte Bart Billet, Dr. Med., von der AZ Delta Krankenhausgruppe in Roeselare, Belgien. Sobald der Stimulator injiziert ist, wird der SandShark nach unten über das Gerät geschoben, bis der noch nicht freigegebene Anker in den Bändern und im starken Bindegewebe steckt. Wenn der röntgendichte Anker am gewünschten Ort ist, zieht der Kliniker den Griff zurück, was die Flügel des Ankers freigibt und sie seitlich in das Gewebe drückt. Dieser Injektionsprozess sichert den Anker am Stimulator und sichert den Stimulator im umgebenden Gewebe, um eine Migration während der Lebensdauer des Mikroimplantats zu verhindern. Der injizierbare Anker wird entlang der Körpernerven platziert und gewährt so eine Bewegungsfreiheit, die andere Neuromodulationsgeräte im Allgemeinen nicht bieten können. Mit dem Ziel, eine Alternative zu Opiaten für die Behandlung von chronischen Schmerzen bereitzustellen, hat Stimwave mit dem Rückenmark-Stimulationssystem (SCS) Stimwave Freedom und dem peripheren Nervenstimulatorsystem (PNS) StimQ Pionierarbeit geleistet. Die Geräte von Stimwave nutzen die Wireless Pain Relief® -Technologie, sind 95 % kleiner als alle anderen Neuromodulationsgeräte auf dem Markt und stellen das einzige System dar, das über eine Vollkörper-3T-MRI-Konditionalität verfügt. Das Rückenmark-Stimulationssystem (SCS) Stimwave Freedom repräsentiert einen lebensverändernden technologischen Durchbruch für mehr als 400 Millionen Menschen, die täglich unter chronischen Schmerzen leiden, und ist eines der vielfältigsten Systeme, das in der Branche erhältlich ist. Das mit dem CE-Kennzeichen markierte SCS-System Freedom-8A kann europäischen Patienten bis zu 64 Elektrodenkontakte bereitstellen und herkömmliche wie auch andere Programmierungsoptionen anbieten, einschließlich Frequenzen von bis zu 10.000 Hz oder Wellenformanpassung. Das SCS-System Freedom-8A mit acht Elektroden benutzt weiterhin den Apple iPad-Programmierer und setzt Bluetooth-Protokolle zur höheren Benutzerfreundlichkeit beim Programmieren der Vielzahl von Optionen ein. Die Geräte übermitteln kleine Energiestöße an bestimmte Nerven und lösen so eine Reaktion aus, die es dem Gehirn ermöglicht, Schmerzwege neu abzubilden, was eine Schmerzlinderung zur Folge hat. Aussagen, die in dieser Pressemitteilung gemacht werden, die zukunftsgerichtet sind oder Überzeugungen, Erwartungen oder Hoffnungen hinsichtlich zukünftiger Vorkommnisse oder erwarteter Ergebnisse ausdrücken, sind zukunftsgerichtete Aussagen. Eine Reihe von Risiken und Unsicherheiten, wie z. B. Risiken im Zusammenhang mit Produktentwicklungs- und Kommerzialisierungsbemühungen, erwarteter Zeitraum oder Ergebnisse von klinischen Studien, endgültiges klinisches Ergebnis und wahrgenommene oder tatsächliche Vorteile der Unternehmensprodukte, Akzeptanz des Produkts durch Markt und Ärzte, Schutz geistigen Eigentums sowie wettbewerbsfähige Angebote, könnte dazu führen, dass tatsächliche Ereignisse in negativer Weise von den in diesen zukunftsgerichteten Aussagen dargestellten Erwartungen abweichen.
News Article | May 27, 2017
BREDA, Paesi Bassi--(BUSINESS WIRE)--Freedom Neuro BV, un distributore di dispositivi medicali per conto di Stimwave Technologies Incorporated, ha annunciato oggi di aver ottenuto l'autorizzazione all'uso del marchio CE per il primo sistema d'ancoraggio iniettabile percutaneo al mondo. Il dispositivo d'ancoraggio iniettabile, da usarsi insieme ai neurostimolatori wireless della società, costituisce una vera e propria innovazione per il fissaggio della tecnologia Wireless Pain Relief® di Stimwave per mezzo di una procedura ambulatoriale minimamente invasiva per quanti sono afflitti da dolore cronico. “Un sistema wireless che mette effettivamente a disposizione del personale clinico tutte le funzionalità di programmazione proprie dei generatori di impulsi impiantabili (implantable pulse generator, IPG), tutte racchiuse entro un singolo dispositivo iniettabile, rappresenta un cambiamento paradigmatico per quanto concerne le opzioni disponibili per offrire ai pazienti la massima personalizzazione per la gestione dei loro profili di dolore” ha spiegato il Dottor Bart Billet del gruppo ospedaliero AZ Delta a Roeselare, Belgio. Una volta iniettato lo stimolatore, SandShark viene fatto scivolare sul dispositivo facendo avanzare il dispositivo d'ancoraggio non spiegato in legamenti e tessuti connettivi robusti. Dopo aver collocato il dispositivo d'ancoraggio nella posizione desiderata, il medico clinico tira indietro il manico spiegando le alette del dispositivo d'ancoraggio spingendole simultaneamente lateralmente dentro il tessuto. Questo processo d'iniezione fissa il dispositivo d'ancoraggio allo stimolatore e quest'ultimo al tessuto circostante onde prevenire la migrazione nel corso della vita utile del microinnesto. Il dispositivo d'ancoraggio iniettabile rimane allineato con i nervi nell'organismo permettendo una libertà di movimento di norma non disponibile con altri dispositivi di neuromodulazione. Adoperandosi ai fini dell'offerta di un'alternativa non oppioide per il trattamento del dolore cronico, Stimwave ha sviluppato i sistemi d'avanguardia Stimwave Freedom Spinal Cord Stimulation (SCS) e StimQ Peripheral Nerve Stimulator (PNS). I dispositivi di Stimwave impiegano la tecnologia Wireless Pain Relief® , sono del 95 per cento più piccoli rispetto a tutti gli altri dispositivi di neuromodulazione rinvenibili in circolazione e sono l'unico sistema compatibile con la risonanza magnetica nucleare a 3 Tesla (RMN 3T) per il corpo intero. Il sistema Stimwave Freedom Spinal Cord Stimulation (SCS) rappresenta un'innovazione tecnologica che potrebbe cambiare la vita alle 400 e passa milioni di persone afflitte quotidianamente da dolore cronico, ed è il sistema più versatile attualmente disponibile in commercio. Il sistema Freedom-8A SCS riportante il marchio CE può offrire ai pazienti europei fino a 64 contatti per elettrodi unitamente alle opzioni di programmazione tradizionali, nonché opzioni di programmazione aggiuntive, comprese frequenze di fino a 10.000 Hz o forme d'onda personalizzate. Il sistema Freedom-8A SCS con otto elettrodi continua ad impiegare il programmatore iPad di Apple, attingendo a protocolli Bluetooth per semplificare la programmazione della gamma di opzioni disponibili. I dispositivi erogano dei piccoli impulsi di energia a nervi specifici innescando una reazione che permette al cervello di eseguire una rimappatura dei percorsi del dolore con conseguente alleviamento del dolore. Stimwave Technologies Incorporated è un'impresa privata operante nel segmento dei dispositivi medicali del settore sanitario impegnata nello sviluppo, nella produzione e nella commercializzazione di neurostimolatori ad alimentazione wireless basati sulla microtecnologia che offrono ai pazienti una soluzione per la gestione del dolore comoda, sicura, minimamente invasiva ed estremamente economica che può essere facilmente incorporata nella loro vita quotidiana. L'obiettivo perseguito da Stimwave consiste nello sviluppare ulteriormente la sua avanzata piattaforma brevettata perché si affermi quale la soluzione standard per la neuromodulazione, ampliando l'accessibilità a favore di pazienti in tutto il mondo e riducendo al tempo stesso l'impatto economico della gestione del dolore. www.stimwave.com
News Article | May 26, 2017
BREDA, Netherlands--(BUSINESS WIRE)--Freedom Neuro BV, a medical device distributor for Stimwave Technologies Incorporated, today announced CE Mark approval for the world’s first Percutaneous Injectable Anchor System. The injectable anchor is utilized in conjunction with the company’s wireless neurostimulator devices to provide true innovation in fixating Stimwave’s Wireless Pain Relief® technology through a minimally-invasive outpatient procedure for those who suffer from chronic pain. “A wireless system that enables clinicians to actually have the full programming capabilities of IPGs, all in a device that can be injected, represents a paradigm shift in the field of options to provide the best in customization for patients to manage their pain profiles,” said Bart Billet, MD, from AZ Delta hospital group in Roeselare, Belgium. Once the stimulator is injected, the SandShark is slid down over the device, progressing the un-deployed anchor into ligaments and strong connective tissues. Once the radiopaque anchor is in the desired location, the clinician pulls back on the handle, simultaneously deploying the wings of the anchor and pushing them laterally into the tissue. This injection process secures the anchor to the stimulator and secures the stimulator to the surrounding tissue to prevent migration throughout the life of the micro-implant. The injectable anchor stays in line with the body’s nerves, allowing for a freedom of movement generally not available in other neuromodulation devices. “The SandShark Percutaneous Injectable Anchor System is a breakthrough for spinal cord stimulators, peripheral nerve stimulators, and all neurostimulation devices,” said Laura Tyler Perryman, founder and CEO of Stimwave. “It allows clinicians to inject a stimulator and its anchor through the same needle puncture port, opening the door for more clinicians to more easily provide patients with our highly efficient stimulators.” Aiming to provide a non-opioid alternative in the treatment of chronic pain, Stimwave has pioneered the Stimwave Freedom Spinal Cord Stimulation (SCS) System and the StimQ Peripheral Nerve Stimulator (PNS) System. Stimwave’s devices use Wireless Pain Relief® technology, are 95 percent smaller than any other neuromodulation device on the market and are the only system to have full body 3T MRI Conditionality. Representing a life-changing technological breakthrough for the more than 400 million people who endure daily chronic pain, the Stimwave Freedom Spinal Cord Stimulation (SCS) System is the most versatile system available in the industry. The CE Marked Freedom-8A SCS System can provide European patients with up to 64 electrode contacts and offer traditional programming options, as well as other programming options, including frequencies up to 10,000 Hz or waveform customization. The Freedom-8A SCS System with eight electrodes continues to utilize the Apple iPad programmer, leveraging Bluetooth protocols for ease of use in programming the variety of options. The devices deliver small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief. Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.
News Article | May 9, 2017
One of the hospitals within AZ Delta used Sectra as its imaging vendor before the merger.Through this contract, Sectra's solution will be used across all AZ Delta's hospital locations and include multiple medical disciplines—radiology, orthopeadics, nuclear medicine and cardiology. In addition to Sectra PACS and VNA, the contract includes advanced visualization tools, integrated speech reporting and Sectra's pre-operative planning solution for orthopaedic surgery. The solution will handle approximately 300,000 examinations a year. "With Sectra as our vendor, we will be able to smoothly expand the solution as we grow, to include additional hospitals and medical disciplines. That advantage, as well as the possibility to geographically work from anywhere, were especially important to us in our choice of vendor. From our earlier experience with Sectra, we know that the solution has very high system availability and that Sectra's support team will be there for us when we need assistance," says Dr. J. Marrannes, Head of the Radiology Department at AZ Delta. Sectra's complete enterprise imaging offering is modular and supports the most image-intense departments—radiology, pathology, cardiology and orthopaedics. Being built on the same technical platform, customers can easily extend a departmental solution to create a comprehensive VNA and enterprise image management solution without major investments or the replacement of existing components For further information, please contact: This information was brought to you by Cision http://news.cision.com http://news.cision.com/sectra/r/growing-belgian-healthcare-provider-orders-enterprise-image-management-solution-from-sectra,c2260139 The following files are available for download:
Neyrinck M.M.,AZ Delta |
Vrielink H.,Sanquin Blood Supply
Journal of Clinical Apheresis | Year: 2015
It's important to work smoothly with your apheresis equipment when you are an apheresis nurse. Attention should be paid to your donor/patient and the product you're collecting. It gives additional value to your work when you are able to calculate the efficiency of your procedures. You must be capable to obtain an optimal product without putting your donor/patient at risk. Not only the total blood volume (TBV) of the donor/patient plays an important role, but also specific blood values influence the apheresis procedure. Therefore, not all donors/patients should be addressed in the same way. Calculation of TBV, extracorporeal volume, and total plasma volume is needed. Many issues determine your procedure time. By knowing the collection efficiency (CE) of your apheresis machine, you can calculate the number of blood volumes to be processed to obtain specific results. You can calculate whether you need one procedure to obtain specific results or more. It's not always needed to process 3X the TBV. In this way, it can be avoided that the donor/patient is needless long connected to the apheresis device. By calculating the CE of each device, you can also compare the various devices for quality control reasons, but also nurses/operators. © 2014 Wiley Periodicals, Inc.
Neyrinck M.,AZ Delta |
Vrielink H.,Sanquin Blood Supply
Journal of Clinical Apheresis | Year: 2015
A training program for apheresis nurses in leukocyte collection and therapeutic apheresis was developed by the Joint Task Force for Apheresis Education and Certification. This is a modular program with theoretical and practical information and knowledge. On request of the Indonesian authorities, in the capital of Indonesia Jakarta, a certification course for apheresis nurses/operators based on the training program described above was organized in December 2013. The course existed of themes related to apheresis, such as hematology, anatomy, physiology, calculations, adverse events, basics of apheresis, nursing aspects, quality, collection of cells for cellular therapies, pediatrics, and therapeutic collections (cell reductions and exchange procedures). A pretest and post-test regarding the knowledge and judgment in the themes described was taken in Bahasa Indonesia or in English. In total, 38 apheresis nurses and 32 physicians participated in the course. In the post-test, the nurses scored in a mean 72/100 and the physicians 77/100 (nurses vs. physicians: P = 0.005), which was significantly better than the results of the pretest (54/100 and 53/100, respectively (P < 0.0001 for both). In conclusion, with this course, 38 apheresis nurses/operators proved a significant increase of knowledge in the theory behind apheresis. This educational program provides an approach to educate and certificate apheresis nurses. It is also shown that also for physicians working in the field of apheresis, this course is of use increasing their knowledge regarding apheresis. © 2014 Wiley Periodicals, Inc.
Hindryckx P.,Ghent University |
Baert F.,AZ Delta |
Hart A.,St Marks Hospital |
Magro F.,University of Porto |
And 2 more authors.
Journal of Crohn's and Colitis | Year: 2015
The clinical trial landscape in ulcerative colitis has evolved significantly in recent decades. Study endpoints have been shifting from mere clinical response to mucosal healing. It has become clear that the choice of combined clinical and endoscopic outcome criteria leads to a reduction in placebo responses, especially when central reading of the endoscopic images is performed. Accumulating evidence suggests that histological remission yields better long-term outcomes for ulcerative colitis patients than mucosal healing alone, and clinical trials with prolonged follow-up will have to address whether histological remission should be the ultimate treatment goal in ulcerative colitis. In recent years there has also been increasing interest in the implementation of patient-reported outcomes in clinical practice and research, and the regulatory authorities have set up guidelines for the development of such outcomes. This paper aims to provide a comprehensive review of historical aspects of clinical trials in ulcerative colitis and to discuss challenges and perspectives for clinical trials in the near future. A thorough analysis of all available landmark literature (both original papers and reviews) on clinical trials in ulcerative colitis was performed. © 2015 European Crohn's and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved.
Terryn S.,AZ Delta |
Terryn S.,University Hospitals Leuven |
De Medts J.,AZ Delta |
De Medts J.,University Hospitals Leuven |
Delsupehe K.,AZ Delta
Otolaryngology - Head and Neck Surgery (United States) | Year: 2015
Objective To evaluate what effects treatments of sleep-disordered breathing have on snoring and sleepiness: snoring surgery including osteotomies, mandibular advancement device (MAD), and continuous positive airway pressure (CPAP). Study Design Single-institution prospective comparative effectiveness trial. Setting University-affiliated secondary care teaching hospital. Subjects and Methods We prospectively studied 224 patients presenting with snoring at our department. All patients underwent detailed evaluation, including symptom questionnaires, clinical examination, polysomnography, and drug-induced sleep endoscopy. Based on these results, a treatment was proposed after multidisciplinary consultation. Treatment was evaluated through 4 questionnaires before treatment and 6 weeks and 6 months after. Treatment success was defined as a global snoring visual analog scale score ≤3 at 6 months. Results A total of 195 patients complied with full workup and were proposed treatment. The mean age was 46 ± 11 years; the mean body mass index, 27 ± 4; and the median apnea-hypopnea index, 10.0 (interquartile range, 4.7-20.1). After discussion, 116 (59.5%) patients agreed to start treatment (46%, surgery; 26% MAD; 28% CPAP). All symptom scores, including Epworth Sleepiness Scale, decreased significantly for all treatments at 6 weeks and 6 months. Treatment was successful in 67% of the surgery patients, 67% of the MAD group, and 76% of the CPAP group. Only 6.7% reported an unchanged snoring score in the surgery group, compared with 13.6% in the MAD group and 9.6 % in the CPAP group. Conclusion Multidisciplinary agreed-on treatment of snoring is effective across the proposed treatments. © Official journal of the American Academy of Otolaryngology-Head and Neck Surgery Foundation 2015.
Cleynen I.,Catholic University of Leuven |
Van Moerkercke W.,AZ Groeninge |
Billiet T.,Catholic University of Leuven |
Vandecandelaere P.,AZ Delta |
And 11 more authors.
Annals of Internal Medicine | Year: 2016
Background: A subgroup of patients with inflammatory bowel disease (IBD) treated with anti-tumor necrosis factor (TNF) antibodies develop skin lesions, but the lesions and their clinical course are not well-characterized. Objective: To describe patients treated with anti-TNF antibodies who did and did not develop skin lesions. Design: Retrospective cohort. Setting: Single IBD tertiary referral center. Patients: 917 consecutive patients with IBD who initiated anti-TNF therapy. Measurements: Skin lesions, patient demographic characteristics, treatments, clinical course, and serologic and genetic markers. Results: During a median follow-up of 3.5 years (interquartile range [IQR], 0.5 to 7.4 years), skin lesions associated with the use of anti-TNF therapy developed in 264 of 917 (29%) patients (psoriasiform eczema, 30.6%; eczema, 23.5%; xerosis cutis, 10.6%; palmoplantar pustulosis, 5.3%; psoriasis, 3.8%; other, 26.1%). Lesions typically developed at flexural regions, genitalia, and the scalp, especially the psoriasiform lesions. Thirty-one percent of women and 26% of men developed lesions. Median cumulative doses (2864 mg/y [IQR, 2203 to 3819 mg/y] and 2927 mg/y [IQR, 2377 to 3667 mg/y]) and trough levels (4.2 μg/mL [IQR, 2.6 to 5.8 μg/mL] and 4.0 μg/mL [IQR, 1.6 to 5.9 μg/mL]) of infliximab were similar in patients with and without lesions. All but 28 patients (11%) were successfully managed without needing to stop therapy because of lesions. Limitation: Retrospective nature and no matched control group of patients not receiving anti-TNF therapy. Conclusion: Skin lesions occur frequently in association with anti-TNF therapy but rarely require discontinuation of therapy. Close surveillance and early referral to a dedicated dermatologist are recommended. Primary Funding Source: Research Foundation Flanders (FWO), Belgium; Geconcerteerde Onderzoekacties of KU Leuven; and Janssen Biologics. Copyright © 2016 American College of Physicians.
Baert F.,AZ Delta
Digestive Diseases | Year: 2015
In recent years it has become clear that therapeutic drug monitoring can be an important tool to optimize outcome and costs of anti TNF treatment including the subcutaneous and fully human monoclonal antibodies. There is a clear dose response curve between early serum concentrations of all monoclonal antibodies and response both short term and long term. The wide variations in early serum concentrations are insufficiently explained by classic pharmacokinetic factors. Low early concentrations can lead to anti-drug antibody formation and ensuing loss of response. Therapeutic drug monitoring allows to rationalize the current practice of dose optimization and the use of concomitant immunomodulator treatment. However more prospective studies are needed before strong recommendations can enter treatment guidelines. © 2015 S. Karger AG, Basel.