Abbott has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its investigational Tendyne transcatheter mitral valve replacement (TMVR) system in a subset of patients with severe mitral annular calcification (MAC).
MAC is a fibrous, degenerative calcification of the mitral valve support ring that is associated with mitral regurgitation (MR), stenosis, or a combination of these valvular lesions, and can pose challenges for surgical correction, limiting treatment options.
Abbott’s Tendyne device is the first-to-world TMVR therapy that offers people with MAC who are not candidates for open-heart surgery a minimally invasive treatment option. Tendyne offers controllable repositioning and full retrievability of the TMVR device, Abbott said in a press release. In compassionate use and feasibility studies to date, operators have achieved 95% technical success in treating patients with severe MAC. Supported by last year’s CE mark, the Tendyne system offers a minimally invasive treatment option when a leaky valve needs to be replaced in this difficult to treat population.