JenaValve Technology said today that the FDA approved the expansion of its investigational device exemption trials for the transcatheter aortic valve replacement it’s developing.
The JenaValve system consists of the Everdur valve and Coronatix delivery catheter. The FDA decision expands the feasibility study from 20 extreme- or high-risk patients to 80 patients with either aortic stenosis or aortic regurgitation, the Irvine, Calif.-based company said. JenaValve said the IDE studies are part of its larger CE Mark program in Europe and New Zealand.
“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,” CEO Victoria Carr-Brendel said in prepared remarks. “The device continues to demonstrate exceptional hemodynamics and best-in-class peri-valvular 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.”
“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 without 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,” added Dr. Martin Leon of the Columbia University Medical Center, who is executive chairman of JenaValve’s clinical program.
The company also said it’s seeking CE Mark approval in the European Union for symptomatic, severe aortic stenosis and hopes to hit the market there during the first half of 2019.