Filtered By:
Condition: Ischemic Stroke
Management: Food and Drug Administration (FDA)

This page shows you your search results in order of date. This is page number 15.

Order by Relevance | Date

Total 232 results found since Jan 2013.

Public Workshop – Acute Ischemic Stroke Medical Devices Trials Workshop, October 6, 2015
The Food and Drug Administration (FDA) is announcing a public Workshop “Acute Ischemic Stroke Medical Devices Trials.” The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated...
Source: Food and Drug Adminstration (FDA): CDRHNew - July 8, 2015 Category: Medical Equipment Source Type: news

Watching, but not waiting: vascular neurology perspective on the disparate regulatory pathways for stroke
Vascular neurologists have keenly watched the Watchman device (Atritech, Plymouth, Minnesota, USA) regulatory approval process. We are, as always, searching for additional options in the prevention and treatment of stroke to better care for our patients, and new approaches to the management of atrial fibrillation play a large part in this effort. Recently, a Food and Drug Administration (FDA) panel voted 13:1 in favor of the Watchman device for the prevention of ischemic stroke in non-valvular atrial fibrillation.1 The panelists came to this decision after reviewing data from large randomized trials that compared anticoagu...
Source: Journal of NeuroInterventional Surgery - May 14, 2015 Category: Neurosurgery Authors: Sheth, S. A., Nogueira, R. G., Noorian, A. R., Liebeskind, D. S. Tags: Editorials Source Type: research

Tissue-type plasminogen activator-binding RNA aptamers inhibiting low-density lipoprotein receptor family-mediated internalisation.
Abstract Recombinant tissue-type plasminogen activator (tPA, trade name Alteplase), currently the only drug approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of cerebral ischaemic stroke, has been implicated in a number of adverse effects reportedly mediated by interactions with the low-density lipoprotein (LDL) family receptors, including neuronal cell death and an increased risk of cerebral haemorrhage. The tissue-type plasminogen activator is the principal initiator of thrombolysis in human physiology, an effect that is mediated directly via localised activation...
Source: Thrombosis and Haemostasis - April 9, 2015 Category: Hematology Authors: Bjerregaard N, Bøtkjær KA, Helsen N, Andreasen PA, Dupont DM Tags: Thromb Haemost Source Type: research

Stroke Mimics and Acute Stroke Evaluation: Clinical Differentiation and Complications after Intravenous Tissue Plasminogen Activator
Intravenous tissue-plasminogen activator remains the only U.S. Food and Drug Administration-approved treatment for acute ischemic stroke. Timely administration of fibrinolysis is balanced with the need for accurate diagnosis. Stroke mimics represent a heterogeneous group of patients presenting with acute-onset focal neurological deficits. If these patients arrive within the extended time window for acute stroke treatment, these stroke mimics may erroneously receive fibrinolytics.
Source: The Journal of Emergency Medicine - March 22, 2015 Category: Emergency Medicine Authors: Peggy L. Nguyen, Jason J. Chang Tags: Clinical Review Source Type: research

State-of-the-Art Endovascular Treatment of Acute Ischemic Stroke.
Authors: Raphaeli G, Mazighi M, Pereira VM, Turjman F, Striefler J Abstract Stroke is the third leading cause of death in the USA. An estimated 795,000 new or recurrent stroke events occur annually, mostly ischemic in nature. Arterial recanalization and subsequent reperfusion performed shortly after symptom onset can help to restore brain function in acute ischemic stroke (AIS). The only treatment currently approved by the United States Food and Drug Administration is intravenous tissue plasminogen activator, administered within 4.5 h of symptom onset. However, this short window often precludes effective interventi...
Source: Advances and Technical Standards in Neurosurgery - December 1, 2014 Category: Neurosurgery Tags: Adv Tech Stand Neurosurg Source Type: research

Reperfusion Therapy in the Acute Management of Ischemic Stroke
Reperfusion, or restoration of blood flow, is an effective means of reducing disability in the setting of acute stroke. Reperfusion therapies, such as intravenous thrombolysis or endovascular and interventional procedures, fit within the existing stroke system of care. There are currently 4 devices cleared by the Food and Drug Administration for recanalization of arterial occlusion in patients with ischemic stroke. Endovascular device technology and advanced imaging technology continue to evolve with newer devices suggesting greater recanalization success. A new paradigm using advanced imaging to select patients in combina...
Source: Cardiology Clinics - November 29, 2014 Category: Cardiology Authors: Michelle P. Lin, Nerses Sanossian Source Type: research

Dabigatran: a new chapter in anticoagulation.
Authors: Ahmed S, Levin V, Malacoff R, Martinez MW Abstract For the last 60 years warfarin has been the cornerstone for chronic anticoagulation in prevention of ischemic strokes and systemic embolization. Warfarin therapy has several limitations including frequent monitoring and various food and significant drug interactions, which make it a less than ideal chronic oral anticoagulant. The continued search for safe, effective, medications with predictable pharmacokinetic profiles has led to newer alternatives. Dabigatran is a potent reversible, competitive direct thrombin inhibitor which is available as the prodrug,...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - November 23, 2014 Category: Cardiology Tags: Cardiovasc Hematol Agents Med Chem Source Type: research

Development of the Trevo ProVue Retriever for intracranial clot removal in acute ischemic stroke
It is estimated that 15 million people worldwide have a stroke each year. Of the estimated 795,000 strokes that occur in the United States annually, the majority are ischemic strokes resulting from an obstruction within a vessel supplying blood to the brain. The treatment goal for these patients is to restore blood flow as quickly as possible. Increasingly, endovascular treatments that interact directly with the clot are being pursued as options. Receiving U.S. Food and Drug Administration clearance in 2012, the Trevo® Retriever is a stent‐like structure to be deployed at the site of an occlusion to allow the occluding ...
Source: Annals of the New York Academy of Sciences - November 14, 2014 Category: Science Authors: Heather C. Prince, Amelia J. Saliba, Jaime Wheeler, Scott Bruder Tags: Original Article Source Type: research

Hyperbaric Oxygen Therapy in Acute Ischemic Stroke: A Review
Stroke, also known as cerebrovascular disease, is a common and serious neurological disease, which is also the fourth leading cause of death in the United States so far. Hyperbaric medicine, as an emerging interdisciplinary subject, has been applied in the treatment of cerebral vascular diseases since the 1960s. Now it is widely used to treat a variety of clinical disorders, especially hypoxia-induced disorders. However, owing to the complex mechanisms of hyperbaric oxygen (HBO) treatment, the therapeutic time window and the undefined dose as well as some common clinical side effects (such as middle ear barotrauma), the wi...
Source: Interventional Neurology - November 7, 2014 Category: Neurology Source Type: research

UCLA Comprehensive Stroke Center honored for stroke care
The UCLA Comprehensive Stroke Center at Ronald Reagan UCLA Medical Center has received a Get With The Guidelines - Stroke award for implementing specific quality improvement measures outlined by the American Heart Association/American Stroke Association for the treatment of stroke patients. Get With The Guidelines - Stroke helps hospital teams provide the most up-to-date, research-based guidelines with the goal of speeding recovery and reducing death and disability for stroke patients. UCLA earned the Gold-Plus Quality Achievement Award award for measures that include aggressive use of medications and risk-reduction therap...
Source: UCLA Newsroom: Health Sciences - October 31, 2014 Category: Universities & Medical Training Source Type: news

Drug delivery to the ischemic brain.
Abstract Cerebral ischemia occurs when blood flow to the brain is insufficient to meet metabolic demand. This can result from cerebral artery occlusion that interrupts blood flow, limits CNS supply of oxygen and glucose, and causes an infarction/ischemic stroke. Ischemia initiates a cascade of molecular events in neurons and cerebrovascular endothelial cells including energy depletion, dissipation of ion gradients, calcium overload, excitotoxicity, oxidative stress, and accumulation of ions and fluid. Blood-brain barrier (BBB) disruption is associated with cerebral ischemia and leads to vasogenic edema, a primary ...
Source: Advances in Pharmacology - October 15, 2014 Category: Drugs & Pharmacology Authors: Thompson BJ, Ronaldson PT Tags: Adv Pharmacol Source Type: research

Endovascular stroke intervention in the very young
Stroke remains the leading cause of adult permanent disability and the third-leading cause of death in United States [1]. In USA, the incident of new or recurrent stroke is approximately 795,000 per year [2], and is predicted to increase to 1.2 million per year by 2025 [3]. It is not surprising, giving these numbers, that the management of stroke is consistently evolving and includes medical treatment as well as interventional management such as open and endovascular surgery. Medical treatment consists of intravenous (IV) recombinant tissue plasminogen activator (rtPA), which is the only therapy approved by the Food and Dr...
Source: Clinical Neurology and Neurosurgery - October 3, 2014 Category: Neurosurgery Authors: Mario Zanaty, Nohra Chalouhi, Robert M. Starke, Stavropoula Tjoumakaris, David Hasan, Shannon Hann, Norman Ajiboye, Kenneth C. Liu, Robert H. Rosenwasser, Philip Manasseh, Pascal Jabbour 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

Early Ischemic Blood Brain Barrier Damage: A Potential Indicator for Hemorrhagic Transformation Following Tissue Plasminogen Activator (tPA) Thrombolysis?
Abstract Tissue plasminogen activator (tPA) thrombolysis, remains the only United States Food and Drug Administration(FDA) approvedtreatmentfor acute ischemia stroke. However, the use of tPA has been profoundly constraineddue to its narrow therapeutic time window and the increased risk of potentially deadly hemorrhagic complications. TPA-associated hemorrhagic transformation (HT) often occurs as a result of catastrophic failure of theblood brain barrier (BBB), wherein the affected cerebral capillaries can no longer hold blood constituents.Due to its direct contribution to edema and HT, reperfusion-associated BBB d...
Source: Current Neurovascular Research - May 30, 2014 Category: Neurology Authors: Jin X, Liu J, Liu W Tags: Curr Neurovasc Res Source Type: research

Parent artery reconstruction for large or giant cerebral aneurysms using a Tubridge flow diverter (PARAT): study protocol for a multicenter, randomized, controlled clinical trial
This study is a multicenter, randomized, controlled clinical trial comparing clinical outcomes for patients with unruptured large/giant intracranial aneurysms treated with either conventional stent-assisted coiling or flow diverter implantation. A total of 124 patients who fulfill the inclusion and exclusion criteria will be randomized into either a treatment group or a control group in the ratio of 1:1. The treatment group will receive Tubridge implantation alone or combined with bared coils, and the control group will be treated with stent-assisted coiling (bare coils). The primary endpoint will be the complete occlusion...
Source: BioMed Central - May 4, 2014 Category: Journals (General) Authors: Yu ZhouPeng-Fei YangYi-Bin FangYi XuBo HongWen-Yuan ZhaoQiang LiRui ZhaoQing-Hai HuangJian-Min Liu Source Type: research