MitraClip G4 system is already approved for use in the US, and the regulatory approval allows its use in Europe and other countries that recognise the CE mark
Abbott has secured CE mark for its fourth-generation MitraClip transcatheter mitral valve repair (TMVr) system, dubbed MitraClip G4, for the treatment of mitral regurgitation (MR).
The minimally invasive mitral valve repair device is already approved in the US, and the current regulatory approval allows its use in Europe and other countries that recognise the CE mark.
Germany’s Universitätsmedizin Mainz heart valve centre head Ralph Stephan Von Bardeleben has first treated the patients using Abbott’s MitraClip G4, in the EU.
Bardeleben said: “Despite being consistently recognized as a problem in patients around the world, MR cannot be treated through the conventional method of open-heart mitral valve surgery in more than half of the people who have this condition.
“The newest MitraClip therapy offers physicians a reliable option when surgical treatment of MR isn’t possible or appropriate, and MitraClip G4’s enhancements allow further customization of the therapy to tailor treatment to individual patient needs.”
MitraClip G4 system comes with four clip sizes and independently controlled grippers
MR is a common heart condition, characterised by improper closing of a mitral valve, making blood flow backwards into the left atrium of the heart instead of flowing to the body parts.
The company said that its MitraClip is a minimally invasive (TMVr) therapy, used as a treatment option for select patients with primary or secondary MR.
MitraClip is a small clip-based device, delivered to the heart through a vein in the leg, to clip portions of the leaflets, or flaps, of the mitral valve together to reduce the backflow of blood. Once in place, the device restores the functioning of the mitral valve and ensures the pumping of oxygenated blood.
According to Abbott, its MitraClip G4 system provides an enhanced clip-based technology for physicians in Europe, along with improved steering functionality during implantation.
The new delivery system provides four clip sizes, including two wider clips, enabling doctors to have varied treatment options that can be customised to a patients’ unique mitral valve anatomy.
Also, the new-generation device also features independently controlled grippers, which allows physicians to hold one or both mitral valve leaflets simultaneously during the MitraClip procedure.
Abbott 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.”