Abbott Tendyne TMVR System Receives FDA Breakthrough Device Designation for Treatment of Severe Mitral Annular Calcification

June 21, 2021—Abbott announced via an email communication that the company has received FDA Breakthrough Device designation for its investigational Tendyne transcatheter mitral valve replacement (TMVR) system in a subset of patients with severe mitral annular calcification (MAC).

According to the company, the Tendyne TMVR system offers controllable repositioning and full retrievability of the TMVR device. In compassionate use and feasibility studies to date, interventionalists have achieved 95% technical success in treating patients with severe MAC.

In January 2020, Abbott announced that the Tendyne system received European CE Mark approval for the treatment of significant mitral regurgitation in patients requiring a heart valve replacement who are not candidates for open heart surgery or transcatheter mitral valve repair.