HeartMate 3 Outflow Graft Clip - Implantable ventricular circulatory assist system

Intended purpose

HeartMate 3 Outflow Graft Clip is an implantable component of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS). The HM3 LVAS is intended to provide haemodynamic support in patients with advanced, refractory left ventricular heart failure. The clip is for attaching to HM3 Sealed Outflow Graft with Bend Relief (also an implantable component of the HM3 LVAS).

Functional description

HM3 Outflow Graft Clip (Clip) is a standalone, implantable component of the HM3 LVAS. The Clip, has been created to attach to the Outflow Graft either during initial implantation or as a corrective measure during surgical intervention to mitigate post-operative Outflow Graft rotation. The Clip is a single piece of titanium that mates with the existing features on both the Outflow Graft Assembly and the Pump Housing, preventing rotation of the Outflow Graft Assembly with respect to the Pump.