JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced U.S. Food and Drug Administration (FDA) approval of expansion of its Investigational Device Exemption (IDE) feasibility studies for the JenaValve Pericardial TAVR System with the Everdur™ transcatheter heart valve (THV) and Coronatix TM Transfemoral Delivery Catheter. The approval expands eligible patient enrollment from 20 patients at extreme or high surgical risk (10 aortic stenosis [AS], 10 aortic regurgitation [AR]) to 80 patients at extreme or high surgical risk (40 AS, 40 AR) at up to 10 U.S. sites.
The prospective IDE studies are part of a larger, ongoing CE Mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers of excellence in Europe and New Zealand.
The JenaValve system is proprietary and differentiated from currently available TAVR devices due to the Everdur THV locator-based technology, designed to enable anatomically-correct, predictable implantation using the new 18-Fr equivalent Coronatix Transfemoral Delivery Catheter. Enrollment has been completed for the AS CE Mark clinical program and is ongoing for the AR CE Mark clinical program… Continue reading.
WASHINGTON, D.C.— The American Institute for Medical and Biological Engineering (AIMBE) has announced the pending induction of Victoria E. Carr-Brendel, Ph.D., Franchise General Manager, VP Program Management, Peripheral Interventions, Boston Scientific Corporation, to its College of Fellows. Dr. Carr-Brendel was nominated, reviewed, and elected by peers and members of the College of Fellows For outstanding contributions to the field of interventional medicine in the treatment of diabetes, hypertension, peripheral vascular diseases, and stroke.