Innovalve transcatheter mitral valve replacement system: Short-term pre-clinical study in pigs

Abstract

Innovalve is a transcatheter mitral valve replacement (TMVR) system with a unique fixation system that aims to grasp the chordae in a rotational maneuver.

Objectives

This study will examine the safety and efficacy of the transapical mitral implantation of Innovalve bioprosthesis in the porcine model.

Methods

Innovalve MV bioprosthesis was implanted in the porcine model (5 pigs) for a duration of 30 days.

Results

The Innovalve bioprosthesis was successfully implanted in all of the animals with accurate positioning, anchoring and good paravalvular sealing. At 30 days after implantation, all animals exhibited normal clinical status without evidence of cardiac impairment. The prosthetic valve seemed adequately adhered to the mitral annulus with fibrous tissue.

Conclusion

We have demonstrated that the implantation of the Innovalve in healthy porcine subjects is feasible and safe and that the valve function and interaction with normal biological tissue is favorable and predictable.