AACHEN, Germany--(BUSINESS WIRE)--Protembis GmbH, a privately held emerging medical device company, announced today the successful completion of 20 clinical cases in its European regulatory study of ...
SANTA ROSA, Calif.--(BUSINESS WIRE)--Claret Medical® today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Sentinelâ„¢ Cerebral Protection ...
SENTINEL trial to evaluate the Safety and Efficacy of the Sentinel CPS in TAVR population SANTA ROSA, CA. -- Claret Medical, Inc., a developer of innovative solutions for cerebral protection during ...
Please provide your email address to receive an email when new articles are posted on . Adults who underwent transcatheter aortic valve replacement with a cerebral protection system experienced fewer ...
MARLBOROUGH, Mass., Sept. 17, 2022 /PRNewswire/ -- Boston Scientific Corporation (NYSE:BSX) has announced results from the PROTECTED TAVR clinical trial evaluating the SENTINELâ„¢ Cerebral Protection ...
Background: Stroke associated with transcatheter aortic valve replacement (TAVR) is a potentially devastating complication. Until recently, the Sentinelâ„¢ Cerebral Protection System (CPS; Boston ...
The Sentinel cerebral protection system (Boston Scientific) was infrequently used during TAVI procedures performed in Germany over a recent 3-year span, and it was not associated with less clinical ...
SANTA CRUZ, Calif., Sept. 9, 2026 /PRNewswire/ -- Emboline, Inc., a medical technology company developing next-generation embolic protection technology, today announced that the U.S. Food and Drug ...
High-risk surgical patients in community hospital settings can safely benefit from the use of new embolus-removing and stent-inserting systems, according to a study presented today at the American ...
Please provide your email address to receive an email when new articles are posted on . The device (TriGuard 3, Keystone Heart) showed potential to prevent larger ischemic brain lesions, Jeffrey W.
GlobalData on MSN
FDA grants 510(k) clearance to Emboliner system for TAVR procedures
The FDA's decision follows a clinical assessment of the Emboliner, including the PROTECT H2H IDE study.
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