Medical device developer JenaValve Technology has started patient enrolment for the US Early Feasibility Study (EFS) for its next-generation Pericardial TAVR System, a minimally invasive therapy to treat symptomatic, severe aortic stenosis (AS) and aortic regurgitation (AR).
The JenaValve Pericardial TAVR System is an investigational device that uses an Everdur transcatheter heart valve (THV) and Coronatix Transfemoral Delivery Catheter.
Everdur THV locator technology is said to facilitate anatomically-correct, predictable implantation via the new 18-Fr equivalent Coronatix Transfemoral Delivery Catheter.
The prospective, single-arm feasibility study is being carried out at multiple centres of excellence under a US Food and Drug Administration (FDA)-approved investigation device exemption (IDE).
This study is part of an ongoing CE-Mark clinical programme designed to assess the JenaValve Pericardial TAVR System for the AS and AR indications at centres in Europe and New Zealand.
While enrolment has been completed for the AS CE-Mark clinical programme, patients are still being recruited for the AR programme.
JenaValve Technology CEO Victoria Carr-Brendel said: “It has been our goal since the early development of our next generation TAVR System to bring this novel technology into the US.
“We are greatly encouraged to initiate enrolment at these prestigious centres under the direction of these physicians, and thank them for their efforts.”
The company is planning to expand the investigational device exemption (IDE) access to patients at certain clinical centres in the US. It intends to work with partners to add new sites to the clinical study.