World Heart Corporation (World Heart), a developer of mechanical circulatory systems, has received unconditional approval from the FDA for the bridge-to-transplant (BTT) study of the Levacor Ventricular Assist Device (VAD).
The company claims that the study enrollment will encompass 160 subjects, a reduction from the approximately 200 subjects of the original statistical plan. As previously reported, the BTT study will begin initially at ten clinical sites.
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.
Alex Martin, president and chief executive officer of WorldHeart, said: “We are especially pleased to receive unconditional approval for the Levacor BTT clinical trial in conjunction with a reduction in total sample size.
“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.”
Jal Jassawalla, executive vice president and chief technology officer of WorldHeart, said: “The Levacor VAD is the full magnetically levitated, bearingless, implantable centrifugal pump to move into clinical trial. We are enthusiastic about the potential for this technology and look forward to demonstrate its safety and efficacy in the upcoming trial.”