Stentys SA (EPA:STNT) said today it won CE Mark approval in the European Union for its self-apposing coronary Xposition S sirolimus-eluting stent, claiming it to be the “world’s 1st and only self-apposing coronary stent.”
The approval came based upon results from a study of the device published last year in the journal Catheterization and Cardiovascular Interventions.
“This CE Marking confirms the adequacy of our technology in this complex setting and now allows us to quickly start the multicentric study that will evaluate the efficacy of Xposition S in 200 patients in this indication,” CEO Gonzague Issenmann said in a press release.
The Princeton, N.J.-based company said its self-apposing stent can adapt to vessels with varying diameters to create an appropriate fit to the vessel wall along the stented length. The Xposition S also features a new delivery catheter to allow for more accurate stent positioning, the company said.
In February, Stentys touted the results of its Apposition IV trial comparing the company’s Stentys self-apposing sirolimus-eluting coronary stent to Medtronic‘s (NYSE:MDT) Resolute stent in patients with ST-segment elevation myocardial infarction.
Results from the study were published in the journal EuroIntervention.
Data from the study indicated that Stentys-stent treated patients demonstrated statistically better stent apposition than those in the balloon-expandable Resolute group at 4 months, with a greater percentage of stents fully covered, the company said. The Stentys SES group showed no reduction in artery lumen diameter with near perfect strut coverage at 9 months, Stentys said.
The trial was originally launched in June 2012, when Stentys announced the trial pitting its Apposition stents against Medtronic’s Resolute.