FDA Clears Abbott’s Fourth-Generation Valve Repair Device
The FDA granted Abbott 510(k) clearance for the fourth generation of its valve repair device, the MitraClip G4.
The device features four clips, providing physicians more treatment options. It also has independently controlled grippers that enable physicians to grasp one or both mitral valve leaflets during the repair procedure. It is delivered through a small slit in the leg, allowing patients to avoid open-heart surgery.
The transcatheter heart valve is used in treating moderate-to-severe or severe mitral regurgitation in patients that have normal heart valves.