JenaValve launches CE Mark study of next-gen TAVR system

JenaValve Technology said this week it launched a new study of its next-generation pericardial transcatheter aortic valve replacement systems using its Coronatix transfemoral delivery catheter.

In the newly launched trial, the Irvine, Calif.-based company will explore the use of the system as a treatment for severe aortic regurgitation in patients who are at high risk for conventional surgical valve replacement.

“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. 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,” national principla investigator Dr. Stephan Baldus of Germany’s Heart Center of the University of Cologne said in a prepared statement.

JenaValve touted that its TAVR system’s Everdur locator-based technology allows for more predictable implantations using its new Coronatix catheter, and said that the system has been used to treat several patients in Germany with aortic regurgitation.

“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 enrollment across multiple sites, building on this positive initial experience with our partners at the Heart Center of the University of Cologne,” JenaValve CEO Victoria Carr-Brendel said in a prepared statement.

The company expects to complete enrollment in the trial by the end of this year, and is hopeful it will receive CE Mark approval in the European Union by the second half of next year.

JenaValve said that it already completed patient enrollment in a CE Mark study of the JenaValve Pericardial TAVR system for the percutaneous treatment of severe aortic stenosis, and is hopeful for approval by the end of this year.

In February, JenaValve said it raised $4.9 million in a new round of debt financing, according to an SEC filing posted this week.

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