FDA Approves Expansion of IDE Trial of the JenaValve TAVR System
December 3, 2018—JenaValve Technology, Inc. announced the FDA has approved expansion of its investigational device exemption (IDE) feasibility studies for the JenaValve pericardial transcatheter aortic valve replacement (TAVR) system with the Everdur transcatheter heart valve (THV) and Coronatix transfemoral delivery catheter.
According to the company, 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 United States sites.
The prospective IDE studies are part of a larger, ongoing CE Mark clinical program that is investigating the JenaValve pericardial TAVR system for the same indications at centers of excellence in Europe and New Zealand.
The system's Everdur THV locator-based technology is designed to enable anatomically correct and predictable implantation using the new 18-F–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.
JenaValve is currently seeking CE Mark approval for the treatment of patients with symptomatic severe AS. The company anticipates commercializing the system in select countries and sites in the first half of 2019.
Martin Leon, MD, serves as Executive Chair of the JenaValve Clinical Development Program. Dr. Leon is Director of the Center for Interventional Vascular Therapy and Professor of Medicine at Columbia University Medical Center in New York, New York.
In JenaValve's announcement, Dr. Leon commented, “We were the first to perform this procedure in the United States 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 United States clinical cases in patients with both AS and AR, and we 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 without a suitable transcatheter option in the United States. 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.”
The JenaValve pericardial TAVR system is available in three sizes intended for aortic annulus diameters ranging in size from 21 to 27 mm. A larger bioprosthesis size is in development. The JenaValve pericardial TAVR system is an investigational device in the United States and internationally, advised the company.