The Xposition S (Stentys), a sirolimus-eluting self-apposing stent, has received CE marking for the treatment of unprotected left main coronary artery disease.
This CE marking was approved on the basis of results from a study published last year in Catheterization and Cardiovascular Interventions, according to a company release.
The stentys self-apposing stent is designed to adapt to vessels with varying diameters, and to ensure optimal fit to the vessel wall along the entire stented length. Xposition S new delivery catheter should enable very accurate stent positioning, according to the press release.
The single centre, retrospective, two-arm, controlled study, conducted by Carlo Briguori, (Clinica Mediterranea, Italy), included 75 consecutive patients with tapered distal unprotected left main coronary artery lesions treated with the Stentys drug eluting stent. The authors concluded that the Stentys stent offers a valid treatment alternative for this indication.
Gonzague Issenmann, co-founder and chief executive officer of Stentys comments, “This CE marking now allows us to quickly start the multicentric study that will evaluate the efficacy of Xposition S in 200 patients in this indication.”