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 CoronatixTM 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.

The Executive Chair of the JenaValve Clinical Development Program Dr. Martin Leon (Director of the Center for Interventional Vascular Therapy and Professor of Medicine at Columbia University Medical Center) said, “We were the first to perform this procedure in the U.S., and have been impressed with the performance of both the delivery system and the valve. We, along with our colleagues at MedStar Washington Hospital Center, conducted the initial U.S. clinical cases in patients with both AS and AR, and believe that those results warrant expanded investigation of the system in the United States. We are especially encouraged by the JenaValve TAVR technology in the minimally invasive treatment of eligible patients with severe AR who are at increased surgical risk. That group of patients, until now, have been wihout a suitable transcatheter option in the U.S. We look forward to welcoming the new sites and physicians into the studies, and continuing to study the versatility and durability of the JenaValve implants.”

“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,” said JenaValve Chief Executive Officer Victoria Carr-Brendel, PhD. “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 forward to furthering our partnership with clinical leaders in the United States.”

JenaValve is currently seeking CE Mark approval for the treatment of patients with symptomatic, severe aortic stenosis, and anticipates commercializing the system in select countries and sites in 1H 2019.