World Heart nets approval for U.S. ventricular assist device study
World Heart has received FDA conditional approval to begin a bridge-to-transplant study of the Levacor ventricular assist device (VAD) at 10 U.S. centers.
The Salt Lake City-based company is required to provide some additional information to the FDA within 45 days, but the study is permitted to begin upon receipt of approval from the various clinical center Institutional Review Boards. Center expansion beyond the initial 10 sites will be based upon a supplemental investigational device exemption application and subsequent FDA approval.
World Heart said the study enrollment will involve approximately 200 subjects, with an opportunity to demonstrate statistical significance through a planned interim analysis at approximately 150 subjects.
The Levacor VAD is the only bearingless, fully magnetically levitated, implantable centrifugal pump to enter clinical trials, according to the company. The pump uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing.
"Full magnetic levitation eliminates dependence on blood properties for rotor suspension, as well as wear within the pump," said Jal S. Jassawalla, WorldHeart's executive vice president and CTO.
The Salt Lake City-based company is required to provide some additional information to the FDA within 45 days, but the study is permitted to begin upon receipt of approval from the various clinical center Institutional Review Boards. Center expansion beyond the initial 10 sites will be based upon a supplemental investigational device exemption application and subsequent FDA approval.
World Heart said the study enrollment will involve approximately 200 subjects, with an opportunity to demonstrate statistical significance through a planned interim analysis at approximately 150 subjects.
The Levacor VAD is the only bearingless, fully magnetically levitated, implantable centrifugal pump to enter clinical trials, according to the company. The pump uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing.
"Full magnetic levitation eliminates dependence on blood properties for rotor suspension, as well as wear within the pump," said Jal S. Jassawalla, WorldHeart's executive vice president and CTO.