JenaValve Technology has announced the initiation of patient enrolment and implantations associated with the CE mark study of its next-generation JenaValve pericardial transcatheter aortic valve implantation (TAVI) system, which uses the Coronatix transfemoral delivery catheter, for the percutaneous treatment of patients with symptomatic, severe aortic regurgitation.
According to a press release, the JenaValve system is proprietary and differentiated from currently available TAVI devices due to the Everdur locator-based technology—designed for more predictable implantation using the new 18Fr equivalent Coronatix transfemoral delivery catheter. The optimised TAVI system has now been used to treat several aortic regurgitation patients in Germany.
The national principal investigator, Stephan Baldus (Heart Center of the University of Cologne, Cologne, Germany), says: “There is currently no TAVI treatment for severe aortic regurgitation cleared by regulators. These patients do not typically develop calcification at the implant site, so other TAVI valves that rely on this narrowing to anchor their devices are at risk of migration. 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 enrolment and treatment with this innovative transcatheter heart valve which has demonstrated low pressure gradients, no new pacemaker implantations and no paravalvular leak.”
JenaValve expects to complete patient enrolment by the end of 2018 at clinical sites in Germany, The Netherlands, New Zealand and the USA. It, the press release reports, anticipates CE mark approval for treating patients with severe aortic regurgitation by the second half of 2019. The Company completed patient enrolment in a CE Mark study of the JenaValve pericardial TAVI system for the percutaneous treatment of severe aortic stenosis and expects approval before the end of 2018.
JenaValve CEO Victoria Carr-Brendel notes: “Our goal is to enable the treatment of patients with severe aortic regurgitation while avoiding many of the side-effects with off-label use of other TAVR devices in this patient population. We are excited to initiate this trial and look forward to expanding enrolment across multiple sites, building on this positive initial experience with our partners at the Heart Center of the University of Cologne.”