WorldHeart gets Greek hospital's approval to begin study of new ventricular device

By E. Janene Geiss

Philadelphia, Nov. 3 - WorldHeart Corp. announced Wednesday that it was notified by the Ethics Committee of St. Luke's Hospital, Thessaloniki, Greece, of its approval to proceed with a clinical feasibility study of WorldHeart's rotary ventricular assist device.

The feasibility study will primarily evaluate the hemodynamic performance of WorldHeart's next-generation continuous flow pump that uses the simplest magnetic levitation design to fully suspend the spinning pump rotor, its only moving part, inside a compact housing, according to a company news release.

The clinical trial 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, officials said.

"This is an important step in bringing our next-generation rotary system into clinical use," Jal S. Jassawalla, WorldHeart's president and chief executive officer, said in the release. "We continue to be on plan toward our objective of starting initial human use of our rotary system in early 2006."

WorldHeart, based in Oakland, Calif., is a medical device company focused on mechanical circulatory support systems.

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