WorldHeart has ended efforts to commercialize its Levacor ventricular assist device (VAD) and will cut its workforce by 42 percent. The company said it will no longer enroll participants in the Levacor bridge-to-transplant (BTT) clinical study but will continue to provide technical support to recipients of the devices and their clinical centers.
Salt Lake City-based WorldHeart, which manufactures VADs for adults, children and infants with heart failure, cited a delay linked to modifications in the Levacor device for its regulatory decision. In February, WorldHeart announced that it had suspended enrollment in the BTT study while it awaited notification from the FDA. It had made changes to the Levacor VAD, which uses a bearingless, fully magnetically levitated implantable centrifugal pump, to address design issues.
At the time, it characterized the FDA’s review and approval as “uncertain."
“With the lengthening BTT clinical study delay associated with the previously announced device refinements, the company does not believe the Levacor VAD can be competitively commercialized,” according to a July 29 statement.
According to filings with the National Institutes of Health, the company planned to enroll approximately 160 patients to study the safety and efficacy of the device in candidates needing a cardiac transplant with presumed non-reversible left ventricular failure. The BTT study was launched in August 2009 and was scheduled to be completed by October 2012. Six hospitals participated in the study.
WorldHeart said that it will focus its resources on smaller, next-generation PediaFlow and MiFlow technologies. The company suggested that the small size of these devices will lead to less invasive VAD surgeries with faster patient recovery times while retaining the blood handling characteristics of the Levacor VAD.
Both PediaFlow and MiFlow technologies are under development. Alex Martin, president and CEO of WorldHeart, said that the company expected to begin animal studies on the MiFlow VAD in 2012 and clinical trials in Europe in 2013. The PediaFlow VAD has been in development since 2005.