JenaValve Technology is making steady progress in the development of its next-generation transcatheter aortic valve replacement (TAVR) system. The Irvine, CA-based company said it has implanted the initial patients in a CE mark study for the treatment of severe aortic regurgitation (AR).
The CE mark study is an international, prospective, non-randomized, single-arm trial of the JenaValve Pericardial TAVR System for the treatment of AR in patients who are at increased risk for conventional surgical valve replacement.
“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,” said Victoria Carr-Brendel, PhD, CEO of JenaValve, in a release. “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.”
The JenaValve system is proprietary and differentiated from currently available TAVR devices due to the Everdur locator-based technology, designed for more predictable implantation using the new 18-Fr equivalent Coronatix Transfemoral Delivery Catheter. The optimized TAVR system has now been used to treat several AR patients in Germany.
JenaValve said it could have CE mark approval for treating patients with severe aortic regurgitation by the second half of 2019. The company completed patient enrollment in a CE Mark study of the JenaValve Pericardial TAVR System for the percutaneous treatment of severe aortic stenosis and expects approval before the end of 2018.
Positive and consistent moves will help JenaValve flourish in the TAVR market, which is already heavily dominated by Edwards Lifesciences and Medtronic in the U.S. Both of the companies popped up several times when MD+DI published six heart-pumping changes in the TAVR market.
Irvine, CA-based Edwards is the noted pioneer of TAVR having received FDA approval for the Sapien Valve in 2011. Dublin-based Medtronic gained approval for its CoreValve system in 2015. Medtronic gained access to the technology when it acquired CoreValve for more than $700 million in 2009.