Does JenaValve ’s New Designation Signal the Start of Another Strong Year for TAVR?

JenaValve is showing significant progress in the plan to get its transcatheter aortic valve replacement (TAVR) system approved. FDA granted the Irvine, CA-based company Breakthrough Device Designation for the JenaValve Pericardial TAVR system. This designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease, a life-threatening and seriously debilitating condition, in patients at high risk for surgery. The JenaValve Pericardial TAVR System consists of a bioprosthesis comprised of a self-expanding nitinol stent with a porcine pericardial valve manufactured using state-of-the-art tissue processing techniques. The TAVR System is available in three sizes to treat a broad range of aortic annulus diameters. In a release, John Kilcoyne, JenaValve CEO, said, “We are clearly encouraged by this positive decision by the FDA regarding the expedited review of our unique TAVR system for patients suffering from severe aortic regurgitation who are at high risk for surgery and for which no transcatheter valve device is labeled or approved in the U.S. We look forward to continuing collaborative interactions with FDA as we move to finalize our clinical development program.” Kilcoyne took over as CEO in January of 2019 after Victoria Carr-Brendel left the company in 4Q18. The firm said it will file for U.S. humanitarian device exemption approval in the second half of this year. The company intends to continue to enroll patient...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news