Singapore based Biosensors International Group received European regulatory approval for its BioFreedom drug coated stent. Unlike most other drug eluting stents, the BioFreedom does not use a polymer to manage the release of Biolimus A9 (umirolimus), a highly lipophilic anti-restenotic derivative of sirolimus that the company developed in-house specifically for this use.
The company is initiating a clinical trial that will guide the commercial release of the BioFreedom stent in the next two years.
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 (DES). 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 0.17 mm as compared with a median instent late lumen loss of 0.35 mm in the Taxus Liberté group. Three year clinical results, presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in October 2012, showed similar rates of MACE (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 DCS and bare-metal stent (BMS), exclusively involving patients at high risk of bleeding. The study has been designed to confirm that BioFreedom is as safe as a BMS in this patient group, and can deliver the anti-restenotic benefit of a DES, with only a one-month course of dual antiplatelet therapy administered to all patients.
Press release: Biosensors Receives CE Mark Approval for BioFreedom™