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Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Boston Scientific closes $270m Claret Medical buy
Boston Scientific (NYSE:BSX) said yesterday that it closed the $270 million buyout of Claret Medical and its Sentinel device, including a $50 million earnout pegged to a reimbursement win that just came in. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. The deal, announced July 20, originally called for an up-front cash payment of $220 million plus the $50 million reimbursement milestone. That milestone was reached when the Centers for Medicare & Medicaid Services granted a New Technology Add...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news

Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates. The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said. The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so. “In pat...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 12, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. MassDevice Q&A: Claret Medical’s Azin Parhizgar on trying to make TAVR safer Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

MassDevice Q & A: Claret Medical ’ s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism. The device has seen a rough road to approval, however, after missing the primary efficacy endpoint in its pivotal trial. Despite that, the device saw nearly unanimous support from an FDA advisory panel and was c...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neurological Surgical Vascular Claret Medical Inc. Source Type: news

Contraindications to Anticoagulation Therapy and Eligibility for Novel Anticoagulants in Older Patients With Atrial Fibrillation
ConclusionsOlder adults with atrial fibrillation rarely have absolute contraindications to oral anticoagulation therapy. Among patients without contraindications, most appeared to be eligible for any anticoagulant, and relatively high‐risk features appeared not to influence warfarin use.This article is protected by copyright. All rights reserved.
Source: Cardiovascular Therapeutics - April 1, 2015 Category: Cardiology Authors: Benjamin A. Steinberg, Melissa A. Greiner, Bradley G. Hammill, Lesley H. Curtis, Emelia J. Benjamin, Susan R. Heckbert, Jonathan P. Piccini Tags: Original Research Article Source Type: research