The battle between stent manufacturers is heating up in Europe, with Biosensors International firing the latest salvo. The company disclosed that it gained a CE mark for BioFreedom, its polymer-free drug-coated stent.
Plans call for a select market launch this year, with a full commercial rollout in 2014.
The European stent market is even more competitive (and arguably, even more oversaturated) than in the U.S. But Biosensors insists its new stent can make a dent because of its technology edge. In essence, its lack of polymer to enable release of a drug--Biolimus A9--is unique. Instead, the stent does the job with a microstructured abluminal surface.
To gain the CE marking, the company relied on data from BioFreedom's first-in-man study, where scientists tested the stent compared to Boston Scientific's ($BSX) Taxus Liberté drug-eluting stent. BioFreedom was comparably effective at 12 months. And major adverse cardiac events at three years were equitable between the two. But BioFreedom gained the edge with median in-stent late lumen loss.
To be sure, Biosensors faces competition from Boston Scientific, Medtronic ($MDT), Biotronik, Abbott ($ABT) and others, as well as upstarts such as Stentys, a French company with a self-apposing bare-metal stent to treat severe heart attacks. But the company also has at least one strategic ally. In October, Biosensors renewed a stent tech licensing deal with Japanese device giant Terumo, which allows Terumo's Nobori drug-eluting stent system to keep using Biosensors' drug and a biodegradable polymer coating technology in Japan and in non-U.S. countries.
If it takes off, however, Biosensors' polymer-free drug-eluting stent could trump that product and gain an edge over all the rest. Meanwhile, plans call for testing BioFreedom in a larger patient population, in order to generate additional data to support the product's initial launch.
- read the release
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