Tendyne receives breakthrough designation for MAC patients


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.


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