Boston Sci grabs CE mark for novel stent

Boston Scientific ($BSX) has picked up European approval for its Synergy drug-eluting stent, a novel device whose polymer coating safely dissolves after three months.

The platinum stent emits everolimus into the coronary artery, and, once its drug content is spent, the device's proprietary coating melts away, leaving just the bare-metal stent and slashing the odds of polymer-related adverse events, Boston Sci says. 

Beyond the bioabsorbable polymer, Boston Sci says the Synergy's thin struts and low profile make it easier to deliver than its competitors. "We believe that the result is a premium workhorse drug-eluting stent that eliminates long-term polymer exposure, promotes optimal healing and provides confident deliverability," Kevin Ballinger, president of the Interventional Cardiology division, said in a statement.

Synergy's CE mark is based on a 6-month study of the device's efficacy, and Boston Sci will roll it out in Europe and around the world early next year. The company has designed a pivotal trial to support a future FDA application, planning to enroll 1,684 patients in 160 sites worldwide.

Boston Sci again posted a decline last quarter, but the company has followed through on its pledge to turn sales around by introducing new devices in its troubled cardio units, including the novel S-ICD and the artery-opening Emerge catheter. Incoming CEO Mike Mahoney--who takes the reins tomorrow--has said he wants to continue the plan laid out by outgoing chief Hank Kucheman: expanding its offerings through R&D and well-timed acquisitions.

- read Boston Sci's statement