Is 2019 Going to Be a Standout Year for TAVR?

JenaValve has won a nod from FDA for expanded IDE enrollment of its transcatheter aortic valve replacement (TAVR) system. The agency’s nod is aimed at feasibility studies for the JenaValve Pericardial TAVR System with the Everdur transcatheter heart valve and expands eligible enrollment from 20 patients to 80 at high or extreme surgical risk. The Irvine, CA-based company said 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. Approval for additional patients in JenaValve’s IDE also comes at a time when the TAVR market is poised for change. New TAVR systems are on the verge of gaining approval and could compete against offerings from both Edwards Lifesciences and Medtronic – two established players in the space. “We are extremely pleased with the initial clinical results and are grateful to the U.S. physicians who made these trials possible as they seek a less invasive approach for these patient populations,” JenaValve CEO Victoria Carr-Brendel, PhD, said in a release. “The device continues to demonstrate exceptional hemodynamics and best-in-class perivalvular leakage results with low pacemaker rates. We are all encouraged by the FDA’s approval to expand this U.S. clinical program and look forwa...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news