FDA approves fourth-generation MitraClip device, MitraClip G4 for treatment of mitral regurgitation

Abbott has announced the company has received FDA approval for the most advanced MitraClip heart valve repair device to treat mitral regurgitation (MR). The latest approval for the fourth-generation MitraClip device, MitraClip G4, puts new enhancements into the hands of physicians across the U.S. by delivering an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time to offer doctors further options when treating mitral valve disease.

MitraClip was approved in the U.S. in 2013 for primary MR patients. In March of 2019, FDA approved MitraClip for secondary MR patients based on results from the COAPT Trial, which investigated MitraClip for treating secondary MR. A landmark trial, COAPT showed a 47% relative reduction in hospitalizations and a 38% relative reduction in mortality. Both primary and secondary MR patients may benefit from MitraClip therapy based on this expanded indication for MitraClip. Since the initial approval, Abbott has introduced two newer generations, G2, G3 and now G4, to support patient care.

The MitraClip device repairs leaky mitral valves without open-heart surgery and is delivered to the heart through a small incision in the leg. The device clips portions of the leaflets, or flaps, of the mitral valve together to reduce the backflow of blood (known as mitral regurgitation, or MR), restoring the heart's ability to pump oxygenated blood more efficiently. To date, MitraClip has helped treat more than 80,000 people worldwide suffering from both primary and secondary MR and is supported by the industry's most extensive body of clinical evidence, including the recent results of the landmark COAPT Trial published in The New England Journal of Medicine in September 2018 .