By Fineline Cube 
US-based medical device giant Abbott Laboratories (NYSE: ABT) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Tendyne transcatheter mitral valve replacement (TMVR) system. This approval allows the company to treat patients suffering from mitral valve disease, specifically those with severe mitral annular calcification (MAC).
Targeting Severe Mitral Annular Calcification
The Tendyne TMVR system is specifically designed for patients with severe MAC, a condition characterized by the buildup of calcium in the valve’s supporting ring structure, known as the annulus. This innovative device offers a new treatment option for patients with this challenging condition.
Regulatory Milestones
The FDA granted Breakthrough Device status to the Tendyne TMVR system in 2021, recognizing its potential to address an unmet medical need. Prior to this, the product received CE Mark approval in the European Union in 2020, marking its earlier entry into international markets.-Fineline Info & Tech