FDA grants unconditional approval for World Heart's Levacor VAD BTT study

World Heart Corporation ("WorldHeart"; Nasdaq: WHRT), a developer of mechanical circulatory systems, announced today that it has received unconditional approval from the U.S. Food and Drug Administration ("FDA") for the bridge-to-transplant ("BTT") study of the Levacor Ventricular Assist Device ("VAD"). Study enrollment will encompass 160 subjects, a reduction from the approximately 200 subjects of the original statistical plan. As previously announced, the BTT study will begin initially at ten clinical sites.

"We are especially pleased to receive unconditional approval for the Levacor BTT clinical trial in conjunction with a significant reduction in total sample size," notes Mr. J. Alex Martin, WorldHeart's President and Chief Executive Officer. "Since receiving the FDA's conditional approval, we have been actively working with involved physicians, their hospital administrations and Institutional Review Boards (IRBs) to attain individual center readiness. We have also been providing in-depth surgical and technical training and expect to have our first implant this quarter."

As described by Mr. Jal S. Jassawalla, WorldHeart's Executive Vice President and Chief Technology Officer, "The Levacor VAD is the only fully magnetically levitated, bearingless, implantable centrifugal pump to move into clinical trial." By using magnetic levitation to fully suspend a spinning rotor, the Levacor VAD's only moving part, the pump is designed to eliminate wear and to provide unobstructed clearances for blood flow across a wide range of operation. Mr. Jassawalla said, "We are enthusiastic about the potential for this technology and look forward to demonstrating its safety and efficacy in the upcoming trial."