STENTYS Announces the CE Marking of the Self-Apposing Stent for Left Main Coronary Artery Disease


PRINCETON, N.J. and PARIS., STENTYS, a medical technology company commercializing the world's first and only Self-Apposing® coronary stent, today announced that Xposition S, the Sirolimus-eluting Self-Apposing stent, received CE Marking for the treatment of Unprotected Left Main Coronary artery disease on the basis of the results from a study published last year in the peer-reviewed journal Catheterization and Cardiovascular Interventions (CCI).

When treating patients with left main coronary artery disease, the large diameter of the left main artery and the significant vessel tapering at that location represents serious challenges for conventional balloonexpandable DES that often result in important stent structural deformations. 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. Xposition S new delivery catheter also enables very accurate stent positioning, a key feature when the lesion is close to the aorta.

The single center, retrospective, two-arm, controlled study, conducted by Carlo Briguori, MD, PhD, (Clinica Mediterranea, Italy), included 75 consecutive patients with tapered distal unprotected left main coronary artery lesions treated with STENTYS DES. 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 commented: “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.”

Source: STENTYS

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