WorldHeart expands bridge-to-transplant Levacor trial
This article was originally published in Clinica
WorldHeart has received approval from the US FDA to add 10 more clinical sites to an ongoing trial of its ventricular assist device, Levacor. The pivotal bridge-to-transplant study will now enrol patients at 20 sites. Salt Lake City, Utah-based WorldHeart began the trial in January (www.clinica.co.uk, 11 January 2010). Levacor is the only fully magnetically levitated, bearingless, implantable centrifugal pump to move into clinical trials, the company claims. The study's expansion comes after leading cardiovascular centres and clinicians "expressed strong interest" in the product, WorldHeart added.