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Total 621 results found since Jan 2013.

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
senfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ, Standardized Data Collection for Cardiovascular Trials Initiative (SCTI) Abstract This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the US Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials in...
Source: Circulation - February 27, 2018 Category: Cardiology Authors: Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, R Tags: Circulation Source Type: research

Choosing the Correct “-ase” in Acute Ischemic Stroke: Alteplase, Tenecteplase, and Reteplase
Alteplase is a tissue plasminogen activator approved for treating acute ischemic stroke (AIS), acute myocardial infarction (AMI), and acute massive pulmonary embolism. Two additional tissue plasminogen activators, tenecteplase and reteplase, are also approved for AMI treatment. However, neither tenecteplase nor reteplase is approved for AIS treatment. The U.S. Food and Drug Administration has received reports of accidental administration of tenecteplase or reteplase instead of alteplase in patients with AIS, which can lead to potential overdose. Primary factors contributing to medication errors include use of the abbreviat...
Source: Advanced Emergency Nursing Journal - July 1, 2019 Category: Emergency Medicine Tags: PROCEDURAL COLUMN Source Type: research

ICU Nursing Care of the Stroke Patient
Almost 25 years ago, in June 1996, the Food and Drug Administration (FDA) approved intravenous (IV) Alteplase as the only acute drug therapy for ischemic stroke. It remains the mainstay drug to date and revolutionized Neurology, Stroke, and Neurocritcal Care. In 2013, the success of several mechanical thrombectomy studies proved the efficacy of endovascular thrombectomy for large vessel occlusions (LVO), both alone and in combination with IV Alteplase. The expanded time window opened this treatment option to a greater number of patients, who are now surviving with fewer deficits.
Source: Critical Care Nursing Clinics of North America - February 1, 2020 Category: Nursing Authors: Mary P. Amatangelo Tags: Preface Source Type: research

FDA OKs First Vagus Nerve Stimulation System for Stroke Rehab FDA OKs First Vagus Nerve Stimulation System for Stroke Rehab
The US Food and Drug Administration has approved a first-of-its kind vagus nerve stimulation system to treat moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke.FDA Approvals
Source: Medscape Neurology and Neurosurgery Headlines - August 27, 2021 Category: Neurology Tags: Neurology & Neurosurgery News Alert Source Type: news

Sustainability of Intravenous Alteplase Administration via Telephone-Based Consult: Data from a US Health System
Despite multiple advances in management over the last few decades, acute ischemic stroke (AIS) is still associated with high morbidity and mortality.1 Intravenous alteplase (IV tPA) was shown to be efficacious and safe for AIS about a quarter century ago2 and remains the only Food and Drug Administration-approved medication for this indication. Though ideal, stroke neurologists may not be available in-person to decide whether to administer tPA to an AIS patient.
Source: Journal of Stroke and Cerebrovascular Diseases - January 27, 2022 Category: Neurology Authors: Sarah E. Nelson, Eric Aldrich, Brenda Johnson, Susan Groman, Richard E. Thompson, Victor Urrutia Source Type: research

Mayo Clinic Minute: How vagus nerve stimulation can help some patients improve their recovery after stroke
A vagus nerve stimulation device, approved by the Food and Drug Administration, is being used in rehabilitation to help patients recovering from an ischemic stroke. If a patient is having trouble using their hand or arm after a stroke, this stimulation device helps create new pathways in the brain as the person performs exercises. This can help the person regain function faster than rehabilitation alone. Dr. Jonathon Parker, a Mayo Clinic neurosurgeon, discusses how the…
Source: News from Mayo Clinic - May 2, 2023 Category: Databases & Libraries Source Type: news

Different risks for heart attack and stroke posed by different hormone therapy formulations
Post-menopausal women whose doctors prescribe hormone replacement therapy for severe hot flashes and other menopause symptoms may want to consider taking low doses of Food and Drug Administration-approved bioidentical forms of estrogen or getting their hormones via a transdermal patch. A new observational study shows bioidentical hormones in transdermal patches may be associated with a lower risk of heart attack and FDA-approved products -- not compounded hormones -- may be associated with a slightly lower risk of stroke compared to synthetic hormones in pill form...
Source: Health News from Medical News Today - September 20, 2013 Category: Consumer Health News Tags: Menopause Source Type: news

Percutaneous management of late leak after lariat transcatheter ligation of the left atrial appendage in patients with atrial fibrillation at high risk for stroke
ABSTRACT Left atrial appendage (LAA) occlusion or ligation is a novel approach to stroke prevention in atrial fibrillation that may obviate the need for long‐term anticoagulation. The Lariat device has received Food and Drug Administration 510K clearance for the approximation of soft tissue and has been applied to transcatheter LAA ligation using a combined trans‐pericardial and transseptal approach. The occurrence of late leak after transcatheter LAA ligation and its percutaneous management has not been previously reported. Herein, we report three cases of late leak with reconstitution of the LAA after initially succe...
Source: Catheterization and Cardiovascular Interventions - October 15, 2013 Category: Cardiovascular & Thoracic Surgery Authors: William J. Mosley, Michael R. Smith, Matthew J. Price Tags: Case Report Source Type: research

FDA looks again at Boston Scientific anti-stroke device
(Reuters) - U.S. Food and Drug Administration staff reviewing data on Boston Scientific Corp's novel anti-stroke device highlighted the implant's failure to meet a key goal for effectiveness in a recent study but said on Monday that other data must be weighed in deciding whether it should be approved.
Source: Reuters: Health - December 9, 2013 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients
The U.S. Food and Drug Administration today approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
Source: Food and Drug Administration - May 8, 2014 Category: American Health Source Type: news

Merck's Zontivity gets FDA approval to reduce heart attacks and stroke risk in patients
Merck has received approval from the US Food and Drug Administration (FDA) for Zontivity (vorapaxar) for people at high-risk of heart attack or stroke.
Source: Pharmaceutical Technology - May 13, 2014 Category: Pharmaceuticals Source Type: news

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

Problems in addition to stroke and bleeding after left atrial appendage closure
We read the article by Waksman et al. about the discussions between the US Food and Drug Administration (FDA) and the sponsor regarding approval of the WATCHMAN-device for interventional left atrial appendage closure (LAAC).[1] We would like to stimulate the discussion by the following contribution: LAAC is primarily intended as an alternative for stroke prevention in patients with atrial fibrillation (AF) in whom oral anticoagulation (OAC) is not possible because of contraindications about a high bleeding risk.
Source: The American Journal of Cardiology - April 24, 2015 Category: Cardiology Authors: Claudia Stöllberger, Josef Finsterer, Birke Schneider Source Type: research

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

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