JenaValve Technology has received approval from the US Food and Drug Administration (FDA) for expanding 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.
The approval extends the 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 sites in the US.
According to JenaValve, the IDE studies are part of a larger ongoing CE Mark clinical program investigating the JenaValve Pericardial TAVR system for the same indications across Europe and New Zealand.
The JenaValve Pericardial system is the company’s currently available TAVR devices due to Everdur THV locator-based technology, which was designed to enable anatomically-correct, predictable implantation using the new 18-Fr equivalent Coronatix Transfemoral Delivery Catheter.
JenaValve completed enrollment for the AS CE Mark clinical program. Enrollment is being carried out For the AR CE Mark clinical program.
JenaValve clinical development program executive chair and Center for Interventional Vascular Therapy Director and Columbia University Medical Center Martin Leon Medicine professor said: “We were the first to perform this procedure in the US, 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 US. 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 without a suitable transcatheter option in the US. 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.”
JenaValve is also seeking CE Mark approval for treating patients with symptomatic, severe aortic stenosis and expects to commercialize the system in some countries and sites in the first half of next year.