The Circulatory System Devices Panel of the Medical Devices Advisory Committee (the Panel), a public advisory committee of the FDA, recommended that World Heart Corporation's (WorldHeart) application for expanded use of its Novacor LVAS as a bridge to transplantation within the United States cannot be approved.

The Novacor LVAS is currently approved for use as a bridge to heart transplantation. WorldHeart had requested an expanded indication that would allow for implant of the device in 'bridge' patients who are not currently transplant candidates but who are expected to become transplant candidates with mechanical circulatory support.

"Our business plan for 2004 did not include an expanded indication and we do not anticipate any adverse effect on our business activities. Approval of the indication as requested would have modestly increased the potential patients within the bridge to transplant indication and we are disappointed that this will not occur," commented Roderick M. Bryden, WorldHeart president and CEO.

WorldHeart has commenced enrollment in its RELIANT (Randomized Evaluation of the Novacor LVAS In A Non-Transplant Population) Trial. The data from this Trial will support an application to the FDA for the destination therapy use of the Novacor LVAS by non-transplant eligible candidates.

Novacor LVAS is an implanted electromagnetically driven pump that provides circulatory support by taking over part or all of the workload of the left ventricle. Novacor LVAS is commercially approved as a bridge to transplantation in the US and Canada.