Edwards Commander Delivery System - Valve-non-specific transcatheter heart valve bioprosthesis

Intended purpose

The delivery system and accessories are intended to facilitate the placement of the bioprosthesis via the transfemoral, transeptal, subclavian/axillary access approaches.

Functional description

The Edwards Commander delivery system facilitates the placement of the bioprosthesis. It consists of a flex catheter to aid in valve alignment to the balloon, tracking, and positioning of the THV. The delivery system includes a tapered tip to facilitate crossing of the valve. The handle contains a flex wheel to control flexing of the flex catheter, and a balloon lock and fine adjustment wheel to facilitate valve alignment and positioning of the valve within the target location.