MitraClip G4 heart valve repair device gets clearance

September 6, 2019 0 By FM

Abbott announced that the US FDA has granted approval for MitraClip heart valve repair device to treat mitral regurgitation.

The latest fourth generation MitraClip G4 has an expanded range of clip sizes, alternative leaflet grasping feature and facilitation of procedure assessment in real-time to offer doctors further options when treating mitral valve disease.

In addition to four clip sizes and the leaflet grasping feature, MitraClip G4 offers the benefit of an upgraded catheter to allow integrated real-time continuous left atrial pressure monitoring during implant. The feature allows physicians 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 optimise patient outcomes.

In March of this year, FDA approved MitraClip for secondary MR patients based on results from the COAPT Trial, which investigated MitraClip for treating secondary MR. COAPT 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. Since the initial approval, Abbott has introduced two newer generations, G2, G3 and now G4.