Stentys Xposition S Receives CE Mark Approval to Treat Unprotected Left Main CAD

March 21, 2016—Stentys announced that the Xposition S sirolimus-eluting self-apposing stent received European CE Mark approval for the treatment of unprotected left main coronary artery disease (CAD). In April 2015, Stentys announced the initial European approval for the device.

According to the company, the Stentys self-apposing stent can adapt to vessels with varying diameters and ensure optimal fit to the vessel wall along the entire stented length. The Xposition S’s new delivery catheter also enables accurate stent positioning, a key feature when the lesion is close to the aorta.

Stentys advised that the approval for treatment of unprotected left main CAD was supported by results from a study published in 2015 by Carlo Briguori, MD, et al in Catheterization and Cardiovascular Interventions (2016;86:E131–E139).

The single-center, retrospective, two-arm, controlled study was conducted at Clinica Mediterranea in Naples, Italy. The study was composed of 75 consecutive patients with tapered distal unprotected left main coronary artery lesions treated with Stentys drug-eluting stents. The investigators concluded that the Stentys device offers a valid treatment alternative for this indication, stated the company.