FDA approves 4th-gen MitraClip for TMVR

Abbott’s fourth-generation MitraClip device was approved by the FDA July 15 to treat mitral regurgitation (MR) in a wider population of patients, the company announced this week.

MitraClip, first approved by the FDA in 2013 for use in primary MR patients, facilitates transcatheter mitral valve repair (TMVR) by “clipping” a patients’ valve leaflets together to reduce backflow of blood into the heart. It was the landmark COAPT trial that again drew attention to the therapy in 2018, and this March the FDA greenlighted the MitraClip for use in patients with secondary MR.

The latest iteration of the system, dubbed MitraClip G4 by Abbott, allows physicians more flexibility with four unique clip sizes, including clips with a wider grasping area to provide additional treatment options. MitraClip G4 also features independently controlled grippers that better help physicians grasp one or both mitral leaflets during TMVR.

The latest device allows physicians to integrate the upgraded MitraClip catheter with a commercially available pressure monitor to continuously track and confirm MR reduction during the implant procedure. The MitraClip catheter can be paired with the monitor for real-time left atrial pressure monitoring during the procedure.

“We are continually innovating the MitraClip technology based on the experience of the physicians implanting the device so we can truly help them improve the lives of their patients,” Neil Moat, MD, chief medical officer of Abbott’s structural heart branch, said in a statement. “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.”