Pioneering Medical Innovations
Boston Scientific (NYSE:BSX) said today it inked a deal worth up to $300 million to acquire Apama Medical and its radiofrequency balloon catheter system designed to treat atrial fibrillation.
June 5, 2017—The FDA has cleared the use of Claret Medical’s Sentinel cerebral protection system in the U.S., making the device the first and only of its kind on the market that reduces the risk of stroke by capturing and removing debris that can break free during transcatheter aortic valve replacement (TAVR) and cause a stroke, the company said.
June 5, 2017—The First and Only Embolic Protection Device Shown to Reduce TAVR Procedural Strokes by 63 Percent
Lower penile bulb radiation dose may be associated with ability to maintain sexual function and potency BEDFORD, Mass.–(BUSINESS WIRE)–Augmenix, Inc.,
February 27, 2017—Claret Medical Inc. announced that in an open public hearing of the US Food and Drug Administration’s Circulatory System Devices Panel held on February 23, virtually all panel members recommended the de novo application of the company’s Sentinel cerebral protection system (CPS) be granted, which would enable commercialization of the device in the United States. A formal vote was not taken, as the Sentinel CPS is a medium-risk accessory device reviewed as a de novo application, advised the company.
Despite the cloud of questions surrounding its clinical efficacy, an FDA advisory panel overwhelmingly recommended approval for the Sentinel Cerebral Protection System. As a de novo application for a lower-risk device, the Sentinel did not require a formal panel vote.
Claret Medical® today announced the results from the SENTINEL pivotal IDE trial of the Sentinel® Cerebral Protection System (CPS), used to protect patients’ brains during transcatheter aortic valve replacement (TAVR).
Sentinel System Shown to Protect the Vast Majority of Brain Regions from Risk of Cerebral Infarcts; Reduces Number and Volume of
FDA clearance in hand, Augmenix is formulating U.S. commercial sales and insurance reimbursement plans for a medical gel designed to
First-of-its-kind Treatment Offers Significant Clinical Benefits to Prostate Cancer Patients Undergoing Radiotherapy WALTHAM, Mass.—April 2, 2015—Augmenix, Inc., a privately held