ICoapsys mitral valve repair system: Percutaneous implantation in an animal model

Abstract

Determine if the iCoapsys device could be accurately and safely implanted using a novel transcatheter system. Functional mitral regurgitation is a ventricular disease characterized by mitral insufficiency in the absence of structural valve abnormalities. It occurs in the presence of ischemic or non-ischemic cardiomyopathy. The Coapsys (surgical) transventricular device, currently undergoing randomized evaluation, offers a more integrated treatment strategy. The iCoapsys transcatheter mitral valve repair system was developed for percutaneous delivery of an implant designed to emulate the surgical (i.e. Coapsys) device. Nine operators tested the ability of this novel catheter system to successfully deliver and position the iCoapsys implant in 12 adult sheep. Post mortem evaluation in this acute model demonstrated precise percutaneous delivery and implantation in all 12 animals using fluoroscopic, coronary angiographic, and epicardial echo guidance. There was no excessive bleeding, hemodynamic compromise or sustained arrhythmias. A novel transcatheter methodology was developed to consistently deliver and accurately position the iCoapsys implant. The percutaneous iCoapsys system was successfully implanted without complication in this acute animal model series.