Irvine-based JenaValve Technology Inc. crossed a major hurdle when its transcatheter aortic valve replacement (TAVR) device for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease was declared a “breakthrough device” by the Food and Drug Administration.
The designation is intended to help patients receive more timely access to breakthrough medical technologies that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases.
Under this program, the FDA will provide JenaValve with priority review as the device is developed in clinical trials.
JenaValve’s TAVR system is for patients suffering from severe aortic regurgitation who are at high risk for surgery and for which no transcatheter valve device is approved in the U.S.
The company said it intends to file for a U.S. humanitarian device exemption in the second half of this year.
JenaValve’s device includes a nitinol stent and a porcine—or pig—pericardial valve. Both Medtronic PLC, which operates its cardio and neuro businesses in Irvine, and Irvine-based Edwards LifeSciences Corp. primarily utilizes bovine valves for their related TAVR.
JenaValve established its Irvine headquarters last year and last January appointed John Kilcoyne as chief executive.
It has additional offices in the U.K. and Germany. It’s backed by Andera Partners, Gimv, Legend Capital, NeoMed Management, Omega Funds, RMM, Valiance Life Sciences and Vi Partners.
Transcatheter treatment for mitral and aortic valves is expected to double from $4 billion in 2018 to $8 billion in 2023.
