Progress toward clinical evaluation of WorldHeart's rotary VAD continues on track. WorldHeart was recently notified by the Ethics Committee of St. Luke's Hospital in Thessaloniki, Greece of approval to proceed with the clinical feasibility study of its rotary VAD. The clinical evaluation is expected to begin in early 2006, pending completion of preclinical testing and acceptance of the clinical investigation application by the Greek ministry of health. We believe that this will be the first use in humans of a bearingless, fully magnetically levitated, centrifugal VAD.
The WorldHeart rotary VAD is an advanced, next-generation, continuous flow pump. Full magnetic levitation of its impellor eliminates wear mechanisms within the pump, and is expected to provide improved blood compatibility by allowing greater clearances and more favorable blood flow around the impeller.
In commenting on recent trial progress and the company’s product platform, Jal S. Jassawalla, WorldHeart’s President and Chief Executive Officer said, “We are pleased with the interest and progress made in our RELIANT trial and in the pre-clinical development of our advanced rotary system. Together with our next-generation pulsatile Novacor II system, we believe we will have the broadest platform of next-generation ‘assist’ and ‘replacement’ systems under development to meet the needs of late and end-stage heart failure patients. We look forward, in 2006, to accelerating RELIANT enrollment, the clinical trial of our rotary system and chronic animal trials of the Novacor II.”