Abbott (NYSE:ABT) announced today that U.S. FDA has approved the MitraClip G4, the most advanced version yet of the company’s transcatheter heart valve repair device to treat mitral regurgitation.
Abbott expanded the number of clip sizes to four for the MitraClip G4, including clips with a wider grasping area, in order to expand the treatment options physicians are able to provide. The G4 also boasts Controlled Gripper Actuation, independently controlled grippers that allow physicians to grasp one or both leaflets during the implantation procedure.
“With the fourth generation of MitraClip, we set out to build a system that would help physicians individualize the therapy to each patient and deliver even more features that can treat both primary and secondary mitral regurgitation,” Dr. Neil Moat, CMO of Abbott’s structural heart business, said in a news release.
The latest MitraClip system also includes an upgraded catheter that allows integrated real-time continuous left atrial pressure monitoring during implant. The monitoring enables physicians during implantation to better determine whether to reposition the MitraClip or place it differently to ensure better patient outcomes.
Acquired in the $410 million acquisition of Evalve in 2009, MitraClip secured its first FDA approval in 2013. Delivered to the heart through a small incision in the leg, the device repairs leaky mitral valves without the patient having to endure open-heart surgery.
