Abbott MitraClip G4 Gets FDA Nod, Valve Repair Options Expand

 | Jul 16, 2019 07:45AM ET

Abbott Laboratories (NYSE:ABT) recently announced FDA approval for its latest version of MitraClip heart valve repair device to treat mitral regurgitation (MR). With the approval for the fourth-generation MitraClip device, MitraClip G4, the company aims to establish a system that would help physicians deliver personalized, patient-focused therapy as well as more features that can treat both primary and secondary MR.

The regulatory breakthrough will boost Abbott’s existing structural heart business.

More About MitraClip G4

The MitraClip system is the first and only transcatheter mitral valve therapy which claims to provide safer and more durable clinical outcome.

It offers physicians an expanded range of clip sizes, a substitute leaflet grasping feature and real-time procedure evaluation for treating mitral valve disease. MitraClip G4 also provides independently-controlled grippers that help physicians grasp one or both leaflets during the procedure, known as Controlled Gripper Actuation.

Equipped with an enhanced catheter, MitraClip G4 facilitates integrated real-time continuous left atrial pressure monitoring during implant. The feature enables doctors to use a commercially-available pressure monitor integrated into the MitraClip catheter to continually monitor and verify MR reduction during the implant procedure.

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