Biosensors has announced CE mark approval for its polymer-free drug-coated stent, BioFreedom.
According to a press release, CE mark approval for BioFreedom was supported by strong data from the BioFreedom First in Man study. In this study, BioFreedom was compared to Boston Scientific’s Taxus Liberté drug-eluting stent. At 12 months, BioFreedom demonstrated equivalent efficacy, measured by in-stent late lumen loss, compared with Taxus Liberté, with a trend towards superiority. Median in-stent late lumen loss in patients receiving BioFreedom was reduced to 0.17mm as compared with a median in-stent late lumen loss of 0.35mm in the Taxus Liberté group. Three-year clinical results, presented at TCT in October 2012, showed similar rates of major adverse cardiac events between BioFreedom and Taxus Liberté, with no evidence of stent thrombosis in either group.
To further evaluate BioFreedom in a larger patient population, Biosensors recently announced initiation of enrolment in LEADERS FREE, the world’s first prospective, randomised double-blind trial between a drug-coated stent and bare metal stent, exclusively involving patients at high risk of bleeding. The study has been designed to confirm that BioFreedom is as safe as a bare metal stent in this patient group, and can deliver the antirestenotic benefit of a drug-eluting stent, with only a one-month course of dual antiplatelet therapy administered to all patients.
This trial will provide additional data to support the launch of BioFreedom in select markets during 2013. The full commercial launch is currently anticipated during 2014.