Biosensors lands CE Mark for BioFreedom polymer-free stent

January 28, 2013 by MassDevice staff

Biosensors International wins CE Mark approval in the European Union for its BioFreedom polymer-free drug-eluting stent.

Biosensors International

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.


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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.