FDA Approves Abbott’s Fourth-Gen MitraClip

By MedTech Intelligence Staff

The G4 gives doctors an additional range of clip sizes, along with enabling real-time procedure assessment.

FDA has approved the latest version of Abbott’s MitraClip, the G4. Intended to treat mitral regurgitation, the minimally invasive next-gen heart valve repair device offers four clip sizes with a wider grasping area and an alternative leaflet grasping feature (Controlled Gripper Actuation). The device also provides real-time left atrial pressure monitoring during implantation, which helps doctors monitor and confirm reduction of mitral regurgitation during the procedure—this aids in helping the doctor decide whether the MitraClip should be repositioned.

“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,” said Neil Moat, M.D., chief medical officer of Abbott’s structural heart business, in a company press release.

Abbott’s MitraClip has been available to patients in the United States since 2013.

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