JenaValve Technology said today it launched an FDA investigational device exemption cleared early feasibility study of its next generation JenaValve pericardial transcatheter aortic valve replacement system.
The newly launched trial will explore the use of the device as a minimally invasive treatment for patients with symptomatic, severe aortic stenosis and symptomatic aortic regurgitation in patients who are considered at extreme or high risk for open surgery.
“Both myself and my CUMC colleagues, Dr. Susheel Kodali and Dr. Torsten Vahl, are extremely pleased to be the first U.S. physicians to treat patients with the new JenaValve TAVR system. The first procedures for both AS and AR patients demonstrated the system’s ease of use and potential that the Everdur valve may be an important addition to the transcatheter valve products. In particular, the JenaValve TAVR technology enables TAVR treatment for patients with severe AR who are at increased surgical risk that until now have not had a suitable transcatheter option in the U.S. We look forward to continuing our work with the JenaValve clinical and product development teams to expand the study of its TAVR technology in the U.S.,” JenaValve clinical development program exec chair Dr. Martin Leon said in a prepared statement.
The prospective, single-arm study will be conducted at several centers in the US and is part of a larger, ongoing CE Mark clinical program seeking the same indications at centers in Europe and New Zealand, the Irvine, Calif.-based company said.
“It has been our goal since the early development of our next generation TAVR System to bring this novel technology into the United States. We are greatly encouraged to initiate enrollment at these prestigious centers under the direction of these physicians, and thank them for their efforts. We will continue to work tirelessly with our clinical partners to expand patient enrollment at new clinical sites in the United States,” CEO Victoria Carr-Brendel said in a press release.
In June, JenaValve said that it launched a new study of its next-generation pericardial transcatheter aortic valve replacement systems using its Coronatix transfemoral delivery catheter.