Enrollment Begins in CE Mark Study for JenaValve's Next-Generation TAVR System to Treat Severe Aortic Regurgitation
June 25, 2018—JenaValve Technology, Inc. announced initiation of patient enrollment in the CE Mark study of its next-generation JenaValve pericardial transcatheter aortic valve replacement (TAVR) system using the Coronatix transfemoral delivery catheter for the percutaneous treatment of patients with symptomatic, severe aortic regurgitation (AR).
The CE Mark study is an international, prospective, nonrandomized, single-arm trial of the JenaValve pericardial TAVR system for the treatment of AR in patients at increased risk for conventional surgical valve replacement.
The device has been initially implanted in several patients with AR in Germany. Patient enrollment is expected to be completed by the end of 2018 at clinical sites in Germany, the Netherlands, New Zealand, and the United States. The company anticipates CE Mark approval for treating patients with severe AR by the second half of 2019. The company has also completed patient enrollment in a CE Mark study of the JenaValve pericardial TAVR system for the percutaneous treatment of severe aortic stenosis and expects approval before the end of 2018.
The company advised that the JenaValve pericardial TAVR system for treating patients with aortic stenosis and/or AR is an investigational device in the United States and internationally. The JenaValve system features the Everdur locator-based technology, designed for more predictable implantation using the new 18-F–equivalent Coronatix transfemoral delivery catheter.
JenaValve Technology's first-generation transapical system, which includes the JenaValve valve with Cathlete Plus delivery system, was commercialized under European CE Mark approval for aortic valve stenosis and aortic valve regurgitation.
The study's National Principal Investigator is Professor Stephan Baldus, MD, from the Heart Center of the University of Cologne in Cologne, Germany. In the company's announcement, Prof. Baldus commented, “There is currently no TAVR treatment for severe AR cleared by regulators. These patients do not typically develop calcification at the implant site, so other TAVR valves that rely on this narrowing to anchor their devices are at risk of migration."
Prof. Baldus continued, "The JenaValve transcatheter valve may address this issue by securing the device with three novel locators that grasp the native valve leaflets. We have just begun study enrollment and treatment with this innovative transcatheter heart valve, which has demonstrated low pressure gradients, no new pacemaker implantations, and no paravalvular leak.”