A Medical Device Daily
World Heart (Salt Lake City) received FDA conditional approval to begin a bridge-to-transplant (BTT) study of the Levacor Ventricular Assist Device (VAD) at ten U.S. centers.
The company is required to provide some additional information to the FDA within 45 days, but the study is permitted to begin upon receipt of clinical center Institutional Review Board (IRB) approvals. WorldHeart has been working closely with a number of clinicians and clinical sites that are interested in participating in the Levacor Study.
The company says the Levacor VAD is the only bearingless, fully magnetically levitated, implantable centrifugal pump to enter clinical trials. The pump uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing. As described by Jal Jassawalla, WorldHeart's executive VP and chief technology officer, "full magnetic levitation eliminates dependence on blood properties for rotor suspension, as well as wear within the pump. This design is expected to optimize blood compatibility by providing unobstructed clearances around the rotor, across a wide range of operation. We look forward to partnering with prominent clinicians at leading transplant centers to demonstrate Levacor safety and efficacy."
Center expansion beyond the initial ten sites will be based upon a supplemental IDE application and subsequent FDA approval. Study enrollment will involve approximately 200 subjects, with an opportunity to demonstrate statistical significance through a planned interim analysis at approximately 150 subjects.