Next-Generation JenaValve Pericardial TAVR System Studied to Treat Severe Aortic Stenosis
April 10, 2018—JenaValve Technology GmbH announced successful patient enrollment in the CE Mark study of the its next-generation JenaValve pericardial transcatheter aortic valve replacement (TAVR) system utilizing the company's Coronatix transfemoral delivery catheter.
The CE Mark study is an international, prospective, nonrandomized, single-arm trial evaluating the JenaValve pericardial TAVR system for the treatment of severe aortic stenosis in patients who are at increased risk for conventional surgical valve replacement. The JenaValve pericardial TAVR system is an investigational device in the United States and internationally.
According to the company, the JenaValve system is composed of the Everdur pericardial aortic valve with locator-based technology designed for more predictable implantation, combined with the new 18-F–compatible Coronatix catheter. The system has been used to treat 10 patients at three sites in Germany and New Zealand with 100% technical success, no reported adverse events, and no moderate or higher paravalvular leakage.
In the company's announcement, the study's German National Principal Investigator, Professor Hendrik Treede, MD, commented, “The novel JenaValve transcatheter valve may address the ongoing clinical needs for these patients. Specifically, early experience with this innovative transcatheter heart valve demonstrates low permanent pacemaker rates, negligible mean pressure gradients across the valve, and no significant paravalvular leaks. Additionally, the new transfemoral system enables rapid, safe, and reliable delivery of this new valve.” Prof. Treede is with Halle University in Halle, Germany.