Stentys has announced the precommercialisation of its Serpentis stent. According to a press release, the sirolimus-eluting stent has a biodegradable coating and is designed for routine procedures. Now that the device has the CE mark, Stentys plans for the stent to be precommercialised by the end of the year to a selection of pilot centres across Europe.
In addition to having a biodegradable coating, Serpentis also has a thin cobalt chromium mesh platform. The press release reports that with Serpentis and Xposition S (designed for more complex indications), Stentys has expanded its product portfolio to cover all requirements. Furthermore, Xposition S has proven its efficacy in the SIZING study, of which the interim results were presented at the 2017 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Denver, USA).
The aim of the SIZING international registry, conducted on 1,300 patients, is the large-scale assessment of Xposition S within the framework of clinical practice. The results of the analysis of the cohort treated with Xposition S (588 patients), the press release claims, validate 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% for thrombotic lesions, in 16% for bifurcations, in 7.5% for vein grafts. Also, 27% of analysed cases presented a substantial vessel diameter (≥4.5mm). Despite these complex anatomies, a low rate of major adverse cardiac events (MACE) was observed after 12 months of monitoring, as well as a low rate of stent thrombosis (0.75%). The positive 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 MACE rate.
Christophe Lottin, chief executive officer of Stentys, comments: “We are very pleased with the launch of Serpentis and firmly believe in its potential. This new stent enables us to address a large number of routine procedures at a competitive price, in addition to our flagship product, Xposition S, of which the clinical benefit, for the treatment of complex lesions and blood vessels with fluctuating diameters, has once again been demonstrated by the SIZING study. With Serpentis and Xposition S, our portfolio now covers a large number of coronary indications and will enable us to support our growth.”
