HeartMate 3 Mini Apical Cuff Kit - Implantable ventricular circulatory assist system

Intended purpose

The HeartMate 3 Mini Apical Cuff Kit is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Mini Apical Cuff is intended to be sutured onto the heart to secure the HeartMate 3 Left Ventricular Assist Device to the heart. It is to be used as an alternative to the HeartMate 3 Apical Cuff when it is required to have more compact suture placement, such as patients with small hearts with increased curvature. The Apical Cuff Holder provides a means to stabilise and manipulate the Mini Apical Cuff during suturing and to check for haemostasis of the tissue-cuff interface.

Functional description

The Mini Apical Cuff has a compliant felt ring attached to a metal ring that is utilised to suture the cuff to heart. The metal ring locks with the HeartMate3 LVAD for securing to heart. Radial and circumferential black lines present on the felt to aid sutures placement. The Apical Cuff Holder is connected to a disk that interfaces with an Apical Cuff. An o-ring present at this interface for a haemostatic connection with the cuff. The holder has a vent connected to a luer port for de-airing.