Stentys: First Clinical Experience With Xposition Shows 100% Implantation Success, Confirms Ease Of Use

Results of SETUP Trial presented at EuroPCR and Published on-line in EuroIntervention

PRINCETON, N.J. & PARIS--(BUSINESS WIRE)--STENTYS (FR0010949404 — STNT), a medical technology company commercializing the world's first and only Self-Apposing^® coronary stent, today announced that the findings of the first Xposition^® clinical experience, as part of the SETUP trial, were presented at the EuroPCR conference. The results of this study were also published today in the online edition of EuroIntervention.

“We are extremely pleased by these clinical results, which are published concurrently to our launch today of Xposition S and prove that Xposition S represents a quantum leap in terms of product design that will lead to faster adoption of the Self-Apposing technology by interventional cardiologists.”

Xposition S is STENTYS’ next-generation sirolimus-eluting Self-Apposing stent. It is delivered by a unique stent delivery system that closely replicates conventional stent implantation techniques: a small balloon peels the sheath containing the stent to release it precisely at the intended location.

The SETUP study was a prospective, single-arm first-in-man study performed in two Dutch centers (Academic Medical Center, Amsterdam, and Albert Schweitzer Hospital, Dordrecht) to evaluate the feasibility of the use of the novel STENTYS Xposition S in de novo coronary lesions. The study enrolled 25 patients and demonstrated 100% technical and angiographic success rates without longitudinal geographical miss on quantitative coronary angiography (QCA). Stent strut malapposition as assessed by optical coherence tomography (OCT) was very low (0.6%) at the end of the procedure.

Principal Investigator Karel Koch, MD, PhD from AMC hospital (Amsterdam, the Netherlands), stated, “STENTYS’ novel balloon delivery system allowed for easy and accurate deployment of all stents at the target lesions, which of note, were performed with real-world lesion complexities, including ostial lesions, highly calcified lesions and lesions with high thrombus burden. We noticed significant improvement over the previous system and see how Xposition S could advance the quality of treatment for heart attack patients or patients with variable artery anatomy.”

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, concluded: “We are extremely pleased by these clinical results, which are published concurrently to our launch today of Xposition S and prove that Xposition S represents a quantum leap in terms of product design that will lead to faster adoption of the Self-Apposing technology by interventional cardiologists.”