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The recall involves updating instructions for use rather than removing the device, POLARx Cryoablation Balloon Catheters, from where they are used or sold, the FDA said. ... Boston Scientific sent ...
An investigation showed that Boston's device, Obsidio Embolic, when used with a specific technique posed a higher risk of bowel ischemia during procedures to stop gastrointestinal (GI) bleeding ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
On March 13, 2015, the U.S. Food and Drug Administration approved the Watchman LAAC Implant, from Boston Scientific, to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular AF who are at increased risk of stroke have an appropriate reason to seek a non-drug alternative to blood thinning medications.
Percutaneous coronary intervention (PCI) is a minimally invasive non-surgical procedure used to treat narrowing of the coronary arteries of the heart found in coronary artery disease. [2] The procedure is used to place and deploy coronary stents, a permanent wire-meshed tube, to open narrowed coronary arteries. PCI is considered 'non-surgical ...
Shares of the medical device maker rose 1.5% in afternoon trading. The approval makes the device, branded Agent, the first drug-coated balloon catheter in the U.S. to treat coronary in-stent ...
A drug-eluting stent (DES) is a small mesh tube that is placed in the arteries to keep them open in the treatment of vascular disease.The stent slowly releases a drug to block cell proliferation (a biological process of cell growth and division), thus preventing the arterial narrowing that can occur after stent implantation.
Medical-device maker Boston Scientific yesterday released data from a clinical trial showing that its Promus Element drug-eluting stent showed advantages over Abbott's Xience V drug-eluting stent ...