BioFreedom, a polymer-free drug-coated stent, has received CE Mark approval in Europe.
BioFreedom (Biosensors International) features a microstructured abluminal surface that permits the controlled release of Biolimus A9 (BA9) without the use of a polymer. BA9 is a lipophilic antirestenotic drug developed by Biosensors specifically for use with stents, according to Singapore-based Biosensors.
BioFreedom showed a strong safety profile compared with the Taxus paclitaxel-eluting stent (Boston Scientific) in one-year results of the first-in-man BioFreedom trial. There were two versions of the stent used in the trial: the BioFreedom low dose and the BioFreedom standard dose. Both doses demonstrated sustained safety up to 12 months, including an absence of stent thrombosis, according to researchers. The one-year results were presented at the Transcatheter Cardiovascular Therapeutics conference in 2010.