news
-
9 January 2020JenaValve Transcatheter Aortic Valve Replacement (TAVR) System Designated by FDA as Breakthrough Device
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.
Related
JenaValve Technology Appoints John T. Kilcoyne as Chief Executive Officer
JenaValve Technology Appoints Keith D. Dawkins, M.D., as Board Member
JenaValve Technology Appoints Pieter Van den Steen As Chief Commercial Officer, General Manager
JenaValve Technology Appoints Janet M. Fauls As Vice President Of Regulatory Affairs
JenaValve Announces Certification of New Transcatheter Heart Valve Manufacturing Facility
Jenavalve bags $26.5M to support growth in competitive TAVR market
JenaValve appoints Peter C. Wulff as Chief Financial Officer
JenaValve appoints Victoria E. Carr-Brendel, Ph.D., as Chief Executive Officer
JenaValve appoints Jan Keltjens Interim Chief Executive Officer
JenaValve names Stefan Schreck, Ph.D., Chief Technology Officer
JenaValve names David J. Drachman Chief Executive Officer
JenaValve announces first implantation of Transapical TAVI System in Sweden
JenaValve expands Series C venture financing round
JenaValve Tavi System receives extended CE mark approval for treatment of aortic insufficiency
JenaValve announces first implantation of Transapical Tavi system in Canada