Biosensors International (PINK:BSNRY) said it won CE Mark approval in the European Union for its BioFreedom drug-eluting stent, which differs from competing coronary stents because it does not use a polymer to bind the drug to the stent.
The Singapore-based medical device company said the stent, which delivers its Biolimus A9 anti-restenosis drug, uses a "microstructured abluminal surface" to permit controlled release of the drug.
In a 12-month, first-in-human study comparing the BioFreedom stent with Boston Scientific‘s (NYSE:BSX) Taxus Liberté stent, the Biosensors device showed improved late lumen loss. Three-year results from the study showed similar rates of major adverse cardiac events, according to a press release.
Biosensors said it’s also running a prospective, randomized double-blind trial comparing the BioFreedom stent and a bare-metal stent in patients with a high risk of bleeding. The company said it plans to launch the device in a few areas this year ahead of a full commercial launch in 2014.