Healthcare company Abbott has secured CE mark approval for its fourth-generation MitraClip transcatheter mitral valve repair system.
MitraClip G4 is the next-generation minimally invasive mitral heart valve repair device that serves as a non-surgical option to treat mitral regurgitation (MR) or a leaky heart valve.
The company already secured FDA approval for the next-generation MitraClip heart valve repair device in the US.
Abbott is offering MitraClip G4 device in four clip sizes
The new MitraClip G4 delivery system is available in four clip sizes, including two wider clips.
Designed to deliver advanced steering during implantation, the new device also includes independently controlled grippers that will help physicians to grasp one or both mitral valve leaflets at a time during the MitraClip procedure.
MitraClip is said to be the first-of-its-kind minimally invasive transcatheter mitral valve repair (TMVr) therapy, which enables to treat select patients with primary or secondary MR.
The small clip-based device will be placed at the heart via a vein in the leg and clips portions of the leaflets, or flaps, of the mitral valve together to minimise the backflow of blood.
MitraClip enables to restore the proper functioning of the mitral valve after placement, as well as improves the heart’s capacity to pump oxygenated blood more efficiently.
Abbott’s structural heart business senior vice president Michael Dale said: “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.
“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.”
Abbott is selling the MitraClip system in the US from 2013 and in Europe from 2008. MitraClip therapy was recently introduced in China.
In June this year, the company secured Japanese approval for the fourth generation of MitraClip device.
In August this year, Abbott initiated enrolling first patients in the TactiFlex PAF IDE study to evaluate a new device to treat paroxysmal atrial fibrillation (PAF), a type of irregular heartbeat.
