FDA "Breakthrough Device" Designation


JenaValve Technology, a US based SJE Group investment, has received “Breakthrough Device” designation from the U.S. Food and Drug Administration (FDA) for the JenaValve Pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease.


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.


JenaValve 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.


The SJE Group congratulates John Kilcoyne, Chief Executive Officer, and the rest of the talented team at JenaValve.

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