FDA News

FDA approves next-generation MitraClip for mitral regurgitation

Neil E. Moat
Neil E. Moat

Abbott announced that a fourth-generation heart valve repair device for the treatment of patients with mitral regurgitation has been approved by the FDA.

The next-generation device (MitraClip G4) has four clip sizes including one with a wider grasping area and independently controlled grippers (Controlled Gripper Actuation) to give physicians the ability to grasp one or both leaflets, according to a press release from the company.

The device also has an upgraded catheter for real-time continuous left atrial pressure monitoring during the procedure, according to the release. This allows physicians to monitor and confirm mitral regurgitation reduction and to determine whether the device should be repositioned.

“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 the structural heart business for Abbott, said in the release. “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.”

Disclosure: Moat is an employee of Abbott.

Neil E. Moat
Neil E. Moat

Abbott announced that a fourth-generation heart valve repair device for the treatment of patients with mitral regurgitation has been approved by the FDA.

The next-generation device (MitraClip G4) has four clip sizes including one with a wider grasping area and independently controlled grippers (Controlled Gripper Actuation) to give physicians the ability to grasp one or both leaflets, according to a press release from the company.

The device also has an upgraded catheter for real-time continuous left atrial pressure monitoring during the procedure, according to the release. This allows physicians to monitor and confirm mitral regurgitation reduction and to determine whether the device should be repositioned.

“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 the structural heart business for Abbott, said in the release. “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.”

Disclosure: Moat is an employee of Abbott.