Medical technology firm Stentys has received CE mark approval for sirolimus-eluting self-apposing stent, Xposition S, to treat unprotected left main coronary artery disease.
The company said 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 poses severe challenges for conventional balloon-expandable DES.
It will frequently result in key stent structural deformations.
The new self-apposing stent can adjust to vessels with varying diameters and ensure optimal fit to the vessel wall along the entire stented length.
Xposition S new delivery catheter also allows accurate stent positioning, said the company.
The approval was based on the single center, retrospective, two-arm and controlled study, which included 75 consecutive patients.
In the trial, patients with tapered distal unprotected left main coronary artery lesions were treated with Stentys DES.
Stentys co-founder and CEO Gonzague Issenmann said: "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."
The company also produces MiStent SES, a coronary DES with new drug delivery mechanism. It is available in Europe, the Middle East, Asia and Latin America.