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Condition: Ischemic Stroke
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Total 31 results found since Jan 2013.

MicroVention Announces FDA Clearance For Thrombectomy Device
SOFIA® Catheter; A New Device for the Revascularization of Patients with Acute Ischemic Stroke ALISO VIEJO, Calif., June 12, 2018 -- (Healthcare Sales & Marketing Network) -- MicroVention, Inc. a U.S.-based subsidiary of Terumo and a global neurova... Devices, Interventional, Neurology, FDA MicroVention, Terumo, SOFIA Catheter, stroke
Source: HSMN NewsFeed - June 12, 2018 Category: Pharmaceuticals Source Type: news

CERENOVUS Receives FDA Clearance For Next Generation Stent Retriever Device Used To Treat Ischemic Stroke
EMBOTRAP II Revascularization Device Captures and Removes Life-threatening Blood Clots, Rapidly Restores Blood Flow IRVINE, Calif., May 21, 2018 -- (Healthcare Sales & Marketing Network) -- CERENOVUS, part of the Johnson & Johnson Medical Devices Compa... Devices, Interventional, Radiology, Neurology, FDA CERENOVUS, Johnson & Johnson, EMBOTRAP, Revascularization, thrombectomy
Source: HSMN NewsFeed - May 21, 2018 Category: Pharmaceuticals Source Type: news

Codman Neuro Announces Acquisition Of Neuravi Limited To Accelerate Innovation In Acute Ischemic Stroke Therapy
Second Acquisition in Months Demonstrates Commitment to Addressing Unmet Needs in Stroke IRVINE, Calif., April 10, 2017 -- (Healthcare Sales & Marketing Network) -- Codman Neuro today announced the acquisition of Neuravi Limited, a privately held Irish... Devices, Neurology, Interventional, Mergers & Acquisitions Codman, Johnson & Johnson, Neuravi Limited, EmboTrap, stroke
Source: HSMN NewsFeed - April 10, 2017 Category: Pharmaceuticals Source Type: news

Re-evaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK): Protocol for an Open-Label, Single-Arm, Multicenter Phase IV Trial for the Treatment of Acute Ischemic Stroke in Chinese Patients
AbstractAcute ischemic stroke (AIS) is a major medical challenge in China. Thrombolytic drugs recommended for the treatment of AIS usually have a narrow time window. Human urinary kallidinogenase (HUK) was approved by the China Food and Drug Administration (CFDA) in 2005 for the treatment of mild to moderate AIS, and it is thus widely used in China. However, large-scale clinical study data for a more complete understanding of various aspects of its safety and efficacy characteristics are still unavailable. The ongoing Reevaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK) trial is designed to reevaluate...
Source: Translational Stroke Research - March 5, 2017 Category: Neurology Source Type: research

4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them! Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression. Previously, Shook was Co-founder, Director, President, an...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog medsider Source Type: news

FDA allows marketing of clot retrieval devices to reduce disability in stroke patients
The U.S. Food and Drug Administration today allowed marketing of two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug (tissue plasminogen activator or t-PA), which needs to be given within three hours of symptom onset.
Source: Food and Drug Administration - September 2, 2016 Category: American Health Source Type: news

Prasugrel Use in Real Life: A Report From the Outpatient Setting in France
The objective of this study was to provide descriptive statistics on patterns of prasugrel usage in the outpatient setting in France. This retrospective study was conducted to describe treatment patterns for prasugrel in the outpatient setting in France using the Intercontinental Marketing Services (IMS) Disease Analyzer database, which collates electronic medical records updated by a nationally representative database of 1200 French general practitioners (GPs). Anonymous data were collected prospectively at each follow‐up visit. The study population consisted of patients with ≥1 prescription for prasugrel in the outpa...
Source: Clinical Cardiology - April 30, 2016 Category: Cardiology Authors: Pierre Sabouret, Magali Taiel‐Sartral, Florence Chartier, Sabine Akiki, Thomas Cuisset Tags: Quality and Outcomes Source Type: research

Rivaroxaban for Preventing Atherothrombotic Events in People with Acute Coronary Syndrome and Elevated Cardiac Biomarkers: An Evidence Review Group Perspective of a NICE Single Technology Appraisal
Abstract As part of its Single Technology Appraisal process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures rivaroxaban (Xarelto, Bayer) to submit evidence of the clinical and cost effectiveness of rivaroxaban for the prevention of adverse outcomes in patients after the acute management of acute coronary syndrome (ACS). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cos...
Source: PharmacoEconomics - December 21, 2015 Category: Health Management Source Type: research

The case for dosing dabigatran: how tailoring dose to patient renal function, weight and age could improve the benefit-risk ratio
Dabigatran is increasingly being used in clinical practice for the thromboprophylaxis in atrial fibrillation as a convenient therapy that needs no drug level monitoring. However, analysis of the data of the same clinical trial that led to the adoption of dabigatran in fixed-dosing regimens has indicated a small subgroup of patients that could be either over-treated, risking bleeding, or under-treated, risking embolism. Additional post-marketing data lends support to the favorable therapeutic profile of dabigatran but at the same time raises doubts about patient characteristics such as weight, age, renal function and their ...
Source: Therapeutic Advances in Neurological Disorders - October 27, 2015 Category: Neurology Authors: Safouris, A., Triantafyllou, N., Parissis, J., Tsivgoulis, G. Tags: Reviews Source Type: research

Thrombolysis in acute ischaemic stroke - time for a rethink?
In the US the licence, or marketing authorisation, for alteplase is limited to 0-3 hours after onset of stroke, but some other countries - including the UK and Australia - have extended the licence to 4.5 hours. In an analysis article on thebmj.com Brian Alper, vice president of evidence based medicine research and development at Dynamed, and colleagues, interpret the evidence to suggest increased mortality with uncertain benefit for its use beyond three hours. Read their full analysis: http://www.bmj.com/content/350/bmj.h1075
Source: The BMJ Podcast - March 18, 2015 Category: Journals (General) Authors: BMJ talk medicine Source Type: podcasts

An update on limitations of intravenous thrombolysis to treat acute ischemic stroke.
Abstract The benefit of intravenous thrombolysis with rt-pa has been demonstrated in acute ischemic stroke up to 4h30 after the first symptoms. The number of patients with stroke treated by rt-pa remains low at less than 5%. In the license of rt-pa in acute ischemic stroke, there are numerous contra-indications explained by the fear of cerebral hemorrhagic complications. These contra-indications are based on the first therapeutic trials published more than 15 years ago, but are not all evidence-based. Large post-marketing registers and new randomized trials have shown a favorable ratio benefit/risk of rt-pa in a...
Source: Presse Medicale - February 16, 2015 Category: Journals (General) Authors: Masingue M, Alamowitch S Tags: Presse Med Source Type: research

Keeping the Genie in the Bottle Growth Hormone and Cardiovascular Disease ∗
Anabolic hormone use is increasingly common and includes replacement in patients with hormone deficiencies, questionable uses in those with borderline-low levels, and clear abuses among athletes aiming to gain a competitive advantage. Recently, direct-to-consumer marketing touting the benefits of “low T” treatment has led to increased testosterone use among middle-aged and older men, despite inadequate cardiovascular safety data. Although the Testosterone in Older Men Trial showed improvements in strength among treated patients, it was prematurely halted due to increased cardiovascular events in the treatment arm (1). ...
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - September 29, 2014 Category: Cardiology Source Type: research

Edaravone improves functional and structural outcomes in animal models of focal cerebral ischemia: A systematic review
Edaravone has been used in patients with acute ischemic stroke in Japan for over 10 years but does not have marketing authorization in Europe or America. Either patients in Europe and America are not receiving an effective treatment, or those in Asia are being given a treatment which is not effective. Finding out which of these is true will require further clinical trials, and a better understanding of its efficacy in animal models may help inform the design of those trials so that it might be tested under conditions where there is the greatest prospect of success. We systematically reviewed the efficacy of edaravone in an...
Source: International Journal of Stroke - October 22, 2013 Category: Neurology Authors: Simiao Wu, Emily Sena, Kieren Egan, Malcolm Macleod, Gillian Mead Tags: Systematic Review Source Type: research

NICE issues final guidance supporting the use of apixaban for prevention of stroke and systemic embolism in non-valvular atrial fibrillation (TA 275)
Source: NICE Area: Evidence > Guidelines NICE has issued final guidance (TA 275) supporting the use of apixaban as an option for preventing stroke and systemic embolism within its marketing authorisation, that is, in people with nonvalvular atrial fibrillation with 1 or more risk factors such as:   . prior stroke or transient ischaemic attack . age 75 years or older . hypertension . diabetes mellitus . symptomatic heart failure.   NICE notes that the decision about whether to start treatment with apixaban should be made after an informed discussion between the clinici...
Source: NeLM - Cardiovascular Medicine - February 27, 2013 Category: Cardiology Source Type: news