Biosensors International fires latest round in EU stent battle
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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