Stentys Begins Precommercialization of Serpentis SES in Europe
November 13, 2017—Stentys announced the precommercialization of Serpentis, its new sirolimus-eluting stent, which is composed of a thin cobalt chromium mesh with a bioabsorbable polymer coating for routine procedures. Codeveloped with a French industrial partner, Serpentis has received European CE Mark approval and will be available by the end of the year to a selection of pilot centers across Europe.
Stentys' Serpentis is dedicated to routine procedures, whereas the company's Xposition S device is designed for more complex indications.
The company advised that the efficacy of the Xposition S was demonstrated in interim results from the SIZING study, which were presented at TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 30 to November 2 in Denver, Colorado.
The SIZING international registry enrolled 1,300 patients to conduct a large-scale assessment of Xposition S in clinical practice. The results of the analysis of the cohort treated with Xposition S (588 patients) validated the benefits of using this self-apposing stent for complex anatomies.
In 36% of cases, Xposition S was selected for lesions on vessels of varying diameters, in 17% of cases for thrombotic lesions, in 16% of cases for bifurcations, in 7.5% of cases for vein grafts, and in 27% of analyzed cases presented a substantial vessel diameter (≥ 4.5 mm).
Stentys reported that despite these complex anatomies, a low rate of major adverse cardiac events was observed after 12 months of monitoring, as well as a low rate of stent thrombosis (0.75%). The results of this exploratory analysis of the SIZING data confirm the benefits of self-apposing coronary stents in the treatment of specific lesions, leading to a low major adverse cardiac event rate, stated the company.