STENTYS Sirolimus-Eluting Stent Confirms Best-in-Class Performance at 3 Years(1)

Follow-up imaging data from APPOSITION IV study to be presented at TCT conference in San Francisco  

PRINCETON, N.J. and PARIS., STENTYS (FR0010949404 — STNT), a medical technology company commercializing the world's first and only Self-Apposing® coronary stent, today announces that three-year follow-up imaging data from the STENTYS arm of the APPOSITION IV clinical study confirms the long-term performance of the sirolimus-eluting Self-Apposing stent. The data will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco, CA.

The data were obtained by Quantitative Coronary Angiography (QCA) and Optical Coherence Tomography (OCT) from a group of patients that were examined three years post-treatment for ST-elevation Myocardial Infarction with the STENTYS stent. The in-stent Late Lumen Loss was 0.08mm (±0.43), while the rate of well-apposed struts was 99.3% and the rate of strut covered by tissue was 99.7%.

Robert-Jan van Geuns, M.D., Ph.D., from Erasmus Medical Center (Rotterdam, the Netherlands), who will present these results today at TCT, said: “These images reinforce our confidence that the STENTYS Sirolimuseluting stent performs very well, not only in the short-term, as previously demonstrated, but also at a much later time point.”

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, stated: “We expect that these exciting long-term results for our Sirolimus-eluting Self-Apposing stent, which is now commercially available in Europe with a new balloon delivery system under the brand Xposition ® , will further drive adoption as cardiologists recognize the potential to optimally treat their patients without the risk of severe malapposition observed with conventional stents.”

About the APPOSITION IV study

APPOSITION IV is a prospective, randomized, four-arm, multi-center study designed to compare the STENTYS Sirolimus eluting stent (90 patients) with Medtronic Resolute® (62 patients) in the treatment of ST-elevation Myocardial Infarction. Patients were followed up at either 4 months (63 patients) or 9 months (89 patients). Stent apposition was statistically better in the STENTYS group than the balloon-expandable group at 4 months, and a greater percentage of STENTYS stents were fully covered by vessel tissue (33% vs 4%, p=0.02), a marker for healing. At 9 months, the STENTYS SES showed no reduction in artery lumen diameter (Late Lumen Loss of 0.04mm ±0.43 under QCA) with a near perfect arterial healing (99% covered struts at 9 months under OCT).

Source: Stentys