JenaValve Receives IDE Approval to Initiate The ALIGN-AR Pivotal PMA Trial
IRVINE, Calif. -- JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced FDA approval for the company to initiate its Investigational Device Exemption (IDE) PMA clinical trial for the Trilogy™ Heart Valve System for severe symptomatic, high-surgical risk aortic regurgitation.
Aortic regurgitation (AR) is a condition that occurs when a patient’s aortic valve does not close properly, resulting in reverse blood flow from the aorta back into the left ventricle. The current treatment for high surgical risk patients who are not candidates for open-heart surgery consists predominantly of medical management and off-label TAVR.
“We are pleased the FDA granted this IDE approval allowing us to continue our pursuit of an aortic regurgitation indication for the Trilogy Heart Valve System,” said John Kilcoyne, JenaValve’s CEO. “We believe the Trilogy Heart Valve System’s unique design provides patients with a minimally invasive transfemoral procedure that has the potential to change the treatment paradigm for what I believe is a vastly underdiagnosed and undertreated AR patient population.”
The ALIGN-AR Pivotal Trial will enroll patients to assess safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in the treatment of high surgical risk patients with symptomatic, severe aortic regurgitation (AR). The study design also allows for patients outside of the US to be included in the trial’s enrollment.
For additional information on The ALIGN-AR Pivotal Trial, visit: clinicaltrials.gov
JenaValve Technology, Inc., with locations in Irvine, California, Leeds, U.K. and Munich, Germany, develops and manufactures transcatheter aortic valve implantation (TAVI) systems to treat patients suffering from aortic valve disease.
JenaValve is backed by Bain Capital Life Sciences and Cormorant Asset Management as well as European and Asian investors, including Andera Partners (formerly Edmond de Rothschild Investment Partners), Gimv (Euronext: GIMB), Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners.
Additional information is available at www.jenavalve.com.