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PubMed | Klinik fur Neuroradiologie, Interventional Neuroradiology and Burgerhospital
Type: Journal Article | Journal: Journal of neurointerventional surgery | Year: 2016

To report our initial experience with the Medina Embolic Device (MED) in unruptured intracranial aneurysms either as sole treatment or in conjunction with additional devices.15 consecutive patients (6 women, 9 men) with unruptured aneurysms were treated between September 2015 and April 2016. The aneurysm fundus measured at least 5mm. We evaluated the angiographic appearances of treated aneurysms at the end of the procedure and at follow-up, the clinical status, complications, and requirement for adjunctive devices.The MED was successfully deployed in all but one case and adjunctive devices were required in 10 cases. Aneurysm locations were middle cerebral artery bifurcation (n=3), internal carotid artery (ICA) bifurcation (n=1), supraclinoid ICA (n=5), posterior communicating artery (n=1), anterior communicating artery (n=2), cavernous ICA (n=2), distal basilar sidewall (n=1), basilar tip (n=1). Three patients had complications although none could be attributed to the MED. Immediate angiographic results were modified Raymond-Roy classification (mRRC) I=1, mRRC II=5, mRRC IIIa=3, mRRC IIIb=5, and one patient showed contrast stasis within the fundus of the aneurysm. Follow-up angiography was available in 11 patients, with four showing complete aneurysm exclusion, six with stable remnants and one patient with an enlarging neck remnant.The MED represents a major step forward in the treatment of intracranial aneurysms. It can result in rapid exclusion of an aneurysm from the circulation and has a good safety profile. We believe that the true value of the MED will be in combining its use with adjunctive devices such as endoluminal flow diverters that will result in rapid aneurysmal exclusion.

News Article | November 30, 2016
Site: globenewswire.com

TORONTO, Nov. 30, 2016 (GLOBE NEWSWIRE) -- Dr. Patricio Stocker, President and CEO of PharmaCielo Ltd., announced the company has appointed a Medical Advisory Board (MAB) to provide guidance on the development of medicinal-grade cannabis oil extracts and related products appropriate for use by clinical practitioners. “Under the guidance of Dr. Delon Human, PharmaCielo Board of Directors member and Chair of the MAB, appointees will be able to provide significant input in the development of our medicinal-grade products through their ability to provide global expertise in the areas of healthcare policy, regulation, medical science and patient insights in addition to their clinical experience,” said Dr. Stocker. Dr. Human has assembled an experienced team of international medical clinicians whose expertise will be leveraged to provide guidance in the development of medicinal-grade cannabis oil based products, as well as international insight and understanding of worldwide healthcare policy and its implications for this emerging global industry. “The Medical Advisory Board will oversee PharmaCielo’s practices and processes, ensuring they are UN-aligned and performed ethically and according to Good Manufacturing and Good Medical Practice,” said Dr. Human.  “During the April 2016 UN General Assembly Special Session on Drugs, the UN and its member states strongly endorsed the need to ensure the accessibility and availability of internationally controlled drugs for medical and scientific purposes, including substances such as cannabinoids. In developing a global framework, this should be promoted within national legal systems, while simultaneously preventing diversion, abuse and trafficking. PharmaCielo has the opportunity to develop the world’s finest quality, naturally grown, pharma-grade cannabis oils.” Four appointees to the MAB were introduced (full biographies are available at www.pharmacielo.com): Dr. Delon Human is the president and CEO of Health Diplomats, a health advisory and consulting practice, providing strategic and technical advice on global health issues to Fortune 500 companies in the pharmaceutical, food, tobacco, nicotine and medical device industries as well as NGOs, governments and foundations. He has acted as adviser to WHO Director-Generals and UN Secretary-General Ban Ki Moon. He is a published author and specializes in global health strategy, corporate and product transformation, harm reduction and health communication. Formerly, he served as the Secretary-General of the International Food and Beverage Alliance (IFBA), which brings together the top food companies in the world. From 1997 to 2005, Dr. Human served as secretary general of the World Medical Association (WMA), the global representative body for physicians. He was instrumental in the establishment of the World Health Professions Alliance, an alliance of the global representative bodies of physicians, nurses, pharmacists, dentists and physical therapists. Dr. Human qualified as a physician in South Africa and completed his postgraduate studies in family medicine and child health in South Africa and Oxford, England. He was a clinician for two decades, part of the pediatric endocrinology research unit at the John Radcliffe Hospital and was involved in the establishment of several medical centers, a hospital and emergency clinic in South Africa. His business studies (MBA) were completed at the Edinburgh Business School. A former chair of the World Medical Association, Dr. Anders Milton is a highly sought-after consultant within the healthcare sector and has served as president of the European Regional Network on HIV/AIDS (ERNA) and as president of the Swedish Red Cross among a number of other positions, including appointment by the Swedish government as chairman of a committee on Swedish HIV/AIDS policies and a member of the Catastrophe Commission formed following the December 2004 tsunami. Recently he led a select committee studying organ donation and transplantation. Previously, Dr. Milton served as president and CEO of the Swedish Medical Association. A director of several public and privately held companies and foundations, Dr. Milton originally studied economics before turning to medicine, and after graduating university as a medical doctor and PhD he served as a clinician at the Department of Nephrology at the University Hospital at Uppsala. Throughout his career he has been engaged in work in support of human rights, ethics of medical practice and safe health care, of which effective pharmacotherapy is an integral part. Dr. Gutiérrez is a neuroradiologist in private practice and Director of the Neuroradiology Division at Centro Avanzado de Diagnostíco Médico (CEDIMED) in Colombia. Previously, Dr. Gutiérrez served at the University of Texas Health Science Center in San Antonio, TX as Associate Professor of Radiology, Vice Chair of Clinical Operations, Medical Director and Director of the Clinical Trials Division at the Radiology Department. He was formerly Director of Medical Development, Diagnostic Imaging and Associate Director of Clinical Development, Diagnostic Imaging for Bayer Healthcare (formerly Berlex Laboratories) in Montville, NJ. Dr. Gutiérrez also served as a medical monitor with Novartis (formerly Ciba-Geigy Labs) in Medellin. Dr. Gutiérrez has been the recipient of several awards for his work, and has been the lead researcher, international researcher and co-investigator on numerous clinical trials.  Regularly published, he has co-edited five medical books and authored or co-authored over 25 book chapters as well as 17 peer-reviewed articles and scores of abstracts and articles published in scientific research journals. Dr. Gutiérrez received a Doctorate in Medicine and Surgery from CES University in Medellin and Specialist in Clinical Radiology from Pontifical Xavierian University / San Ignacio Hospital in Bogota. He completed a research fellowship in Neuroradiology at Thomas Jefferson University / TJU Hospital in Philadelphia, PA and a visiting fellowship in Interventional Neuroradiology at the University of Miami / Jackson Memorial Hospital. Dr. Soto is Chairman of the Department of Radiology at Boston Medical Center and a Professor of Radiology at the Boston University School of Medicine. He has previously served as a general medical practitioner with the Hospital San Antonio de Prado in Colombia, section head of Body Imaging at University of San Vicente de Paúl Hospital, radiologist at CEDIMED in Medellin, assistant professor of Radiology at the University of Antioquia and was vice chairman of Boston Medical Center’s Department of Radiology for ten years. A native of Medellin with citizenship in both Colombia and the United States, Dr. Soto received his Doctor in Medicine and Surgery and Specialist in Diagnostic Radiology from CES University’s Health Sciences Institute in Medellin, and completed a Radiology Body Imaging Fellowship at Boston University Medical Center. Dr. Soto has received honors and awards from the Colombian Ministry of Education, Medellin Medicine Academy, Boston University Medical Center and numerous professional societies.  An extensively published researcher, Dr. Soto is a member of the editorial boards of Radiology and Abdominal Imaging, has edited seven books and has published over 85 original research papers and more than 35 reviews, book chapters and case reports. PharmaCielo Ltd. (the “Company”) is a global company privately held and headquartered in Canada, with a focus on processing and supplying all natural, medicinal-grade cannabis oil extracts and related products to large channel distributors.  The Company’s principal (and wholly-owned) subsidiary is PharmaCielo Colombia Holdings S.A.S., headquartered at its Nursery and Propagation Centre located in Rionegro, Colombia. The boards of directors and executive teams of both PharmaCielo and PharmaCielo Colombia Holdings are comprised of a diversely talented group of international business executives and specialists with relevant and varied expertise.  PharmaCielo recognized the significant role that Colombia’s ideal location will play in building a sustainable business in the medical cannabis industry, and the Company, together with its directors and executives, has built a compelling business plan focused on supplying the international marketplace. This press release contains forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or “recurring” or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements involve known and unknown risks, uncertainties and other factors, such as demand for the Company’s products, currency exchange changes and risks, internal funding and the financial condition of the Company, product roll-out, competition, technological changes, and other commercial matters involving the Company, its products, and the markets in which the Company operates, as well as general economic conditions, which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Actual results and developments are likely to differ, and may differ materially, from those expressed or implied by the forward-looking statements contained in this press release. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. However, any further disclosures made on related subjects in subsequent reports should be consulted.

PubMed | Interventional Neuroradiology Center, Hopital Bicetre, University of Reims Champagne Ardenne, Toulouse University Hospital Center and 3 more.
Type: Journal Article | Journal: Neuroradiology | Year: 2016

The Woven EndoBridge (WEB) system is an innovative device under evaluation for its capacity to treat wide-neck bifurcation intracranial aneurysms. The purpose of this study is to evaluate the use of the different occlusion scales available in clinical practice.Seven WEB-experienced neurointerventionalists were provided with 30 angiographic follow-up data sets and asked to grade each evaluation point according to the Bictre Occlusion Scale Score(BOSS), firstly based on DSA images only then using additional C-Arm VasoCT analysis. This BOSS evaluation was then converted into the WEB Occlusion Scale (WOS) and into a dichotomized scale (complete occlusion or not). To estimate the inter-rater agreement among the seven raters, an overall kappa coefficient [1] and its standard error (SE) were computed.Using the five-grade BOSS, raters showed moderate agreement (kappa=0.56). Using the three-grade WOS, agreement appeared slightly better (kappa=0.59). Strongest inter-rater agreement was observed with a dichotomized version of the scale (complete occlusion or not), which enabled an almost perfect agreement (kappa=0.88). VasoCT consistently enhanced the agreement particularly with regards depicting intra-WEB residual filling.The WOS is a consistent means to angiographically evaluate the WEB device efficiency. But the five-grade BOSS scale allows to identify aneurysm subgroups with differing risks of recurrence and/or rehemorrhage, which needs to be separated especially at the initial phase of evaluation of this innovative device. The additional use of VasoCT allows better inter-rater agreement in evaluating occlusion and specially in depicting intra-WEB persistent filling.

Castro M.A.,CONICET | Olivares M.C.A.,Favaloro University | Putman C.M.,Interventional Neuroradiology | Cebral J.R.,George Mason University
Medical and Biological Engineering and Computing | Year: 2014

The aim of this work was to determine whether or not Newtonian rheology assumption in image-based patient-specific computational fluid dynamics (CFD) cerebrovascular models harboring cerebral aneurysms may affect the hemodynamics characteristics, which have been previously associated with aneurysm progression and rupture. Ten patients with cerebral aneurysms with lobulations were considered. CFD models were reconstructed from 3DRA and 4DCTA images by means of region growing, deformable models, and an advancing front technique. Patient-specific FEM blood flow simulations were performed under Newtonian and Casson rheological models. Wall shear stress (WSS) maps were created and distributions were compared at the end diastole. Regions of lower WSS (lobulation) and higher WSS (neck) were identified. WSS changes in time were analyzed. Maximum, minimum and time-averaged values were calculated and statistically compared. WSS characterization remained unchanged. At high WSS regions, Casson rheology systematically produced higher WSS minimum, maximum and time-averaged values. However, those differences were not statistically significant. At low WSS regions, when averaging over all cases, the Casson model produced higher stresses, although in some cases the Newtonian model did. However, those differences were not significant either. There is no evidence that Newtonian model overestimates WSS. Differences are not statistically significant. © 2014, International Federation for Medical and Biological Engineering.

Vanzin J.R.,Interventional Neuroradiology of the Neurology and Neurosurgery Service | Abud D.G.,University of Sao Paulo | Rezende M.T.S.,Federal University of Minas Gerais | Moret J.,Interventional Neuroradiology
Arquivos de Neuro-Psiquiatria | Year: 2012

Objective: The Brazilian public health system determines a quantity of coils allowed to treat a cerebral aneurysm. The goal of this paper was to determine the number of coils necessary to treat an aneurysm based on size. Methods: All patients harboring an aneurysm treated by endovascular approach between 1999 and 2003 were reviewed. Results: There were 952 aneurysms included. Mean diameter sac was 8.2 mm with 7.9 coils per aneurysm. Out of 462 small aneurysms, mean size was 4.8 mm, with 4.6 coils/aneurysm used. A total of 315 medium aneurysms were treated, mean size was 8.6 mm, with 8.2 coils. Out of 135 large, mean size was 17 mm, with 16.1 coils. Forty giant aneurysms were treated with a mean size of 32 mm and 28.7 coils. Conclusions: We propose size as a reference to predict the number of coils necessary to treat each aneurysm: one coil for each millimeter of diameter.

Vanzin J.R.,Interventional Neuroradiology | Mounayer C.,Interventional Neuroradiology | Abud D.G.,University of Sao Paulo | D'Agostini Annes R.,University Of Passo Fundo | Moret J.,Interventional Neuroradiology
Interventional Neuroradiology | Year: 2012

This study was designed in an attempt to identify the risk factors that could be significantly associated with angiographic recurrences after selective endovascular treatment of aneurysms with inert platinum coils. A retrospective analysis of all patients with selective endovascular coil occlusion of intracranial aneurysms was prospectively collected from 1999 to 2003. There were 455 aneurysms treated with inert platinum coils and followed by digital subtraction angiography. Angiographic results were classified according Roy and Raymond's classification. Recurrences were subjectively divided into minor and major. The most significant predictors for angiographic recurrences were determined by ANOVAs logistic regression, Cochran-Mantel-Haenszel test, Fisher exact probability. Short-term (4.3±1.4 months) follow-up angiograms were available in 377 aneurysms, middle-term (14.1±4.0 months) in 327 and long-term (37.4±11.5 months) in 180. Recurrences were found in 26.8% of treated aneurysms with a mean of 21±15.7 months of follow-up. Major recurrences needing retreatment were present in 8.8% during a mean period follow-up of 17.9±12.29 months after the initial endovascular treatment. One patient (0.2%) experienced a bleed during the follow-up period. Recurrences after endovascular treatment of aneurysms with inert platinum coils are frequent, but hemorrhages are unusual. Single aneurysm, ruptured aneurysm, neck greater than 4 mm and time of follow-up were risk factors for recurrence after endovascular treatment. The retreatment of recurrent aneurysm decreases the risk of major recurrences 9.8 times. Long-term angiogram monitoring is necessary for the population with significant recurrence predictors.

PubMed | Hospital Universitario La Paz, Hospital Reina Sofia, Hospital Universitario Puerta Of Hierro Majadahonda, Hospital Universitario Ramon y Cajal and 6 more.
Type: Journal Article | Journal: Journal of neurointerventional surgery | Year: 2016

The Pipeline Flex embolization device has some peculiarities in comparison with the previous generation device. Despite recent reports of the modified delivery system, its safety is still unknown.To illustrate the intraprocedural and periprocedural complication rate with this new device in 30 consecutive patients.Clinical, procedural, and angiographic data, including aneurysm size and location, device or devices used, angiographic and clinical data were analyzed.30 patients harboring 30 aneurysms were analyzed. 39 devices were placed properly. Multiple Pipeline embolization devices (PEDs) were used in 7 cases. In 28 devices the distal end opened fully from the beginning with a complete wall apposition. In the remaining 11 devices, distal-end opening of the devices was instant but partial, but fully opened easily after recapture. Among the 30 procedures, recapture and reposition of the Pipeline Flex was performed four times owing to proximal migration/malposition of the device during delivery. Four intraprocedural/periprocedural complications occurred, of which 2 resulted in major complications, with neurologic deficits persisting for longer than 7days. The 30-day morbidity rate was 6.6%, with no deaths. No aneurysm rupture or parenchymal hemorrhage was seen.The Pipeline Flex embolization device allows more precise and controlled deployment than the first-generation device. The number of devices and the complication rate during the learning curve are lower than reported with the first-generation PED. The new delivery system and the resheathing maneuvers do not seem to increase the intraprocedural complication rate in comparison with the first-generation PED.

PubMed | Hospital Clinico Universitario Of Valladolid and Interventional Neuroradiology
Type: Journal Article | Journal: Journal of neurointerventional surgery | Year: 2016

The pipeline embolization device (PED) has become a routine firstline option for the treatment of an increasing population of intracranial aneurysms at many neurovascular centers. Intraprocedural complications during PED deployment, or complications associated with migration of the device, are rarely reported problems. Significant mismatch in luminal diameter between the inflow vessel and the outflow vessel or excessive dragging-stretching of the PED have been related to watermelon seed or accordion effects, respectively, resulting in stent migration. Here we present a novel balloon technique that was successfully used to realign an in situ flow diverting stent that had prolapsed into a large aneurysm. This represents a useful salvage technique and should be considered when encountering this potential complication.

PubMed | Hospital Clinico Universitario Of Valladolid and Interventional Neuroradiology
Type: | Journal: BMJ case reports | Year: 2016

The pipeline embolization device (PED) has become a routine firstline option for the treatment of an increasing population of intracranial aneurysms at many neurovascular centers. Intraprocedural complications during PED deployment, or complications associated with migration of the device, are rarely reported problems. Significant mismatch in luminal diameter between the inflow vessel and the outflow vessel or excessive dragging-stretching of the PED have been related to watermelon seed or accordion effects, respectively, resulting in stent migration. Here we present a novel balloon technique that was successfully used to realign an in situ flow diverting stent that had prolapsed into a large aneurysm. This represents a useful salvage technique and should be considered when encountering this potential complication.

Research and Markets has announced the addition of the "US Market Overview for Neuromodulation, Neurovascular, Neurosurgical and Monitoring Devices 2017 - MedView" report to their offering. The full report suite on the U.S. market for neurological devices includes cerebrospinal fluid shunts, cerebrospinal fluid external drainage systems, intracranial pressure monitoring devices, detachable coils, liquid embolics, catheters, guidewires, balloon occlusion devices, neurovascular stents and flow diversion stents, spinal cord stimulators, vagus nerve stimulators, sacral nerve stimulators, deep brain stimulators, gastric electric stimulators, neuroendoscopes, stereotactic frames, stereotactic frameless systems, ultrasonic aspirators, aneurysm clips, neurosurgical microscopes, intrathecal pumps and mechanical thrombectomy devices. Stereotaxy has become the standard of care in neurosurgery therefore the market for stereotactic systems is saturated, limiting growth in market value. Innovative technology and updated features and software will be required to encourage growth. New competitors have entered the neuromodulation market which will drive competitive pressure in technological advancement and pricing. This will have the greatest impact on the spinal cord stimulator and deep brain stimulator markets. One of the major market drivers for neurological devices is the patient and physicians demand for minimally invasive procedures. This has been driving the growth in interventional neuroradiology and neuroendoscopy. This has led to procedural growth in endovascular embolization treatments and a decline in aneurysm clipping procedures treatments. Access devices are becoming increasingly technologically advanced and various embolization devices have been released in recent years. One of the major emerging trends is the growth of mechanical thrombectomy devices for ischemic stroke. These devices extend the window for treatment of patients compared to medical therapy alone and can provide dramatically improved clinical outcomes. 2. Disease Overview 2.1 Basic Anatomy 2.2 Disease Pathology And Disorders 2.2.1 Introduction 2.2.2 General Diagnostics And Neurosurgery 2.2.3 Tumor And Brain Cancer 2.2.4 Brain Arteriovenous Malformations 2.2.5 Ischemic Stroke 2.2.6 Brain Aneurysm 2.2.7 Disorders Related To Cerebrospinal Fluids And Intracranial Pressure Hydrocephalus And Intracranial Pressure Disorder Cerebral Edema 2.2.8 Indication For Neuromodulation 2.2.9 Traumatic Brain Injury 3. U.S. Neuromodulation, Neurovascular, Neurosurgical And Monitoring Device Market Overview 3.1 Introduction 3.1.1 Cerebrospinal Fluid Management 3.1.2 Interventional Neuroradiology 3.1.3 Neuromodulation 3.2 Market Overview 3.3 Trend Analysis By Segment 3.4 Drivers And Limiters 3.4.1 Market Drivers Cerebrospinal Fluid Management Interventional Neuroradiology Neuromodulation Neurosurgery 3.4.2 Market Limiters Cerebrospinal Fluid Management Interventional Neuroradiology Neuromodulation Neurosurgery 3.5 Competitive Market Share Analysis 3.6 Company Profiles For more information about this report visit http://www.researchandmarkets.com/research/qxwkzk/us_market

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