The Natick-based stents giant is calling its new nickel-titanium alloy stent, designed to treat iliac artery disease, the “next generation” of nitinol device. The stent launched in Europe in April.
The trial involves 123 patients at 25 sites in the U.S. and will examine rates of death within 30 days, myocardial infarction during hospitalization, target vessel revascularization through nine months and amputation of the treated limb through nine months.
Another trial comparing BSC’s Taxus Liberté and J&J’s Nevo stents didn’t turn out so well for BoSci. The six-month study showed 64 percent less restenosis at six months with its experimental drug-eluting stent than with the Liberté and 86 percent fewer re-blockages.
The Nevo device, made by J&J subsidiary Cordis Corp., features hundreds of small drug/polymer reservoirs that leaves roughly 75 percent of the stent bare (previous stent designs covered the entire device with drug/polymer coatings). The coating is absorbed by the body after about three months.
Boston Scientific’s Labcoat acquisitions is also working on a biodegradable polymer, which the company expects to submit for regulatory approval by the end of June, according to the Reuters news service. The Labcoat technology could be used on both its Liberté and Element platforms.