Abbott (NYSE:ABT) announced today that it received CE Mark approval in Europe for its fourth-generation MitraClip system.
MitraClip G4, the latest installment of the Abbot Park, Ill.-based company’s transcatheter mitral valve repair (TMVR) system, is now approved for use in countries recognizing the CE Mark as a non-surgical option for treating mitral regurgitation (MR) or a leaky heart valve. MitraClip is delivered to the heart through a vein in the leg and clips portions of the leaflets or flaps of the mitral valve together to reduce the backflow of blood.
The device already has approval in the U.S., having won an FDA nod in July 2019. The MitraClip system secured its first FDA approval in 2013 and, in January of this year, the FDA approved a clinical trial to study the effectiveness of MitraClip in people eligible for open-heart surgery.
MitraClip G4 offers the system’s first-of-its-kind, clip-based technology with four available clip sizes that include advanced steering during implantation and independently controlled grippers for physicians to grasp one or both mitral valve leaflets at a time during the procedure.
“An enduring measure of our mission to help people live better lives through better health is our success in advancing new standards of care for the treatment of structural heart diseases,” Abbott structural heart business senior VP Michael Dale said in a news release. “This CE Mark, along with other recent approvals and advancements for our MitraClip device, underscores the need for MitraClip’s innovative therapy – which has become a preferred choice for the treatment of mitral regurgitation around the world.”
