FDA Approves Abbott's Next-Generation MitraClip G4 to Treat Mitral Regurgitation

July 15, 2019—Abbott Structural Heart received FDA approval for the fourth-generation MitraClip G4 heart valve repair device to treat mitral regurgitation (MR). The company stated that the new device features an expanded range of clip sizes, an alternative leaflet grasping feature, and facilitation of procedure assessment in real time during the treatment of mitral valve disease.

According to Abbott, MitraClip is available in four clip sizes, including clips with a wider grasping area. MitraClip G4 also offers independently controlled grippers that allow physicians to grasp one or both leaflets during the "Controlled Gripper Actuation" procedure.

Additionally, the upgraded catheter allows integrated real-time continuous left atrial pressure monitoring during implantation. This feature allows interventionalists to use a commercially available pressure monitor integrated into the MitraClip catheter to continuously monitor and confirm MR reduction during the implant procedure and help them determine whether MitraClip should be repositioned or placed differently to optimize patient outcomes.

The MitraClip system has been commercially available in the United States since 2013 when it was first approved for primary MR patients. Since then, Abbott has introduced new generations of MitraClip including the G2, G3, and now G4.

In March 2019, the FDA approved MitraClip for secondary MR patients based on results from the COAPT trial. COAPT, which investigated MitraClip for treating secondary MR, showed a 47% relative reduction in hospitalizations and a 38% relative reduction in mortality. Both primary and secondary MR patients may benefit from MitraClip therapy based on this expanded indication for MitraClip, advised Abbott.