Abstract: A system and method for the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a crossing catheter having a prolapseable or curved tip. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make plications in the subvalvular region of the mitral valve annulus. Fourth, a “C” shaped retainer with deformable ends is deployed by the plication device in order to retain the plicated tissue in the plicated form.

Abstract: A system and method for the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a crossing catheter having a prolapseable or curved tip. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make plications in the subvalvular region of the mitral valve annulus. Fourth, a “C” shaped retainer with deformable ends is deployed by the plication device in order to retain the plicated tissue in the plicated form. A transseptal approach may be used to plicate and retain tissue on the atrial side of the mitral valve to achieve a reduction in mitral valve regurgitation.

Abstract: A system for the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular tissue each fixed by a retaining clip is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a prolapsable crossing catheter. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. The plication device is then used to make plications in the subvalvular region of the mitral valve annulus. Fourth, a formable linear retainer clip is deployed by the plication device in order to retain the plicated tissue in the plicated form. The formable linear retainer is formed into a reverse “C” clip by the jaws of the plication device acting in conjunction with a retainer pusher.

Abstract: A system and method for the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a crossing catheter having a prolapseable or curved tip. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make plications in the subvalvular region of the mitral valve annulus. Fourth, a “C” shaped retainer with deformable ends is deployed by the plication device in order to retain the plicated tissue in the plicated form. A transseptal approach may be used to plicate and retain tissue on the atrial side of the mitral valve to achieve a reduction in mitral valve regurgitation.