Transcatheter aortic valve replacement (TAVR) systems manufacturer JenaValve Technology has started patient enrolment and implantations for the CE Mark study of its new JenaValve Pericardial TAVR System.
The implantations were carried out using the Coronatix Transfemoral Delivery Catheter for treating patients suffering from symptomatic, severe aortic regurgitation (AR).
The CE Mark study will involve a non-randomised single-arm trial of the JenaValve Pericardial TAVR System to assess its effectiveness in treating AR in patients showing an increased risk to undergo conventional surgical valve replacement.
Utilising the new 18-Fr equivalent Coronatix Transfemoral Delivery Catheter, the system enables more predictable implantation.
The national Principal Investigator, Dr Stephan Baldus said: “There is currently no TAVR treatment for severe aortic regurgitation 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.
“The JenaValve transcatheter valve may address this issue by securing the device with three novel locators that grasp the native valve leaflets.”
JenaValve Technology aims to complete patient enrolment by the end of this year at the clinical sites in Germany, the Netherlands, the US and New Zealand.
It expects to secure CE Mark approval to treat patients with severe aortic regurgitation by the second half of next year.