FDA Approves Abbott’s Minimally Invasive Mitral Valve Device

The FDA has approved Abbott's Tendyne transcatheter mitral valve replacement (TMVR) system, making it the first device to replace the mitral valve without open-heart surgery. Intended for patients with severe mitral annular calcification (MAC) who are at high surgical risk or ineligible for repair, Tendyne offers a minimally invasive, self-expanding, and repositionable solution in multiple sizes. Clinical data indicate that Tendyne reduces heart failure hospitalizations and improves patients' quality of life and functional status. This approval expands Abbott's structural heart portfolio, which includes devices such as MitraClip and TriClip. Financial analysts expect the development to enhance Abbott’s market position due to its leadership in mitral valve therapies. Experts note the device addresses a critical treatment gap for high-risk patients with complex mitral valve disease.