JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease, announced it has received “Breakthrough Device” designation from the U.S. Food and Drug Administration (FDA). This designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease, a life-threatening and seriously debilitating condition, in patients at high risk for surgery. 

The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough medical technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide JenaValve with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.

John Kilcoyne, Chief Executive Officer, said, “We are clearly encouraged by this positive decision by the FDA regarding the expedited review of our unique TAVR system for patients suffering from severe aortic regurgitation who are at high risk for surgery and for which no transcatheter valve device is labeled or approved in the U.S. We look forward to continued collaborative interactions with the FDA as we move to finalize our clinical development program. In addition to the FDA, I would like to thank our physician investigators who are leading the clinical program to evaluate the safety and effectiveness of this important technology in the treatment of AR-dominant disease.”

JenaValve is the sponsor of a U.S. investigational device exemption (IDE) and is conducting a multicenter clinical program for the treatment of patients with severe AR who are at high risk for surgery. It is anticipated that the Company will file for U.S. humanitarian device exemption (HDE) approval in the second half of 2020. The Company intends to continue to enroll patients in the clinical program throughout the year to support a future premarket approval (PMA) application to the FDA as part of the Breakthrough Device program.