3rd-generation MitraClip device approved by FDA
The FDA has approved the third generation of the MitraClip, which treats mitral regurgitation without open-heart surgery, device manufacturer Abbott announced July 12.
Moderate to severe mitral regurgitation affects one in 10 adults over the age of 75, according to Abbott’s press release. The MitraClip is delivered via a transcatheter approach and has been used as a less-invasive alternative for patients who are too old or frail to undergo open-heart surgery. It secures the leaflets of leaky mitral valves so that blood pumps more efficiently and doesn’t flow backward into the heart.
First approved in Europe in 2008 and the U.S. in 2013, the device has been used in more than 65,000 patients worldwide, Abbott said. The third-generation includes a second clip size with longer arms and other improvements designed for more precise steering and deployment in complex anatomies.
"Physicians rely on MitraClip as an alternative to surgery for patients who aren't surgical candidates and may need treatment to relieve their symptoms or to survive," Swiss cardiologist Francesco Maisano, MD, said in the press release. "The enhanced MitraClip design allows for even more precise navigation, accuracy, and stability during valve repairs, which may be important when treating people with more complex or advanced valve disease."
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.