STENTYS has entered into a five-year agreement with Micell Technologies to be the exclusive distributor of the MiStent coronary stent worldwide (excluding the United States, Canada, China, South Korea and Japan).
Gonzague Issenmann, chief executive officer and co-founder of STENTYS, explains: “This exciting new product is designed to outperform the market-leading workhorse stents thanks to a unique coating technology. Our customers will now have the opportunity to use MiStent for routine procedures and the STENTYS Self-Apposing stent for complex vessel anatomy that requires optimal apposition, both of which are designed for safe vessel healing and improved patient outcomes.”
The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) is a balloon-expandable stent designed for rapid healing and slow progression of coronary artery disease. The bioabsorbable coating of MiStent SES disappears within three months of implantation to promote fast vessel healing. However, sirolimus elution is precisely and consistently controlled up to nine months after implantation, thereby inhibiting vessel re-narrowing. These unique properties of both fast polymer absorption and sustained drug release are made possible by an innovative proprietary coating technology that allows sirolimus to be encapsulated as tiny crystals; once the polymer is gone, the crystals slowly dissolve into the tissue surrounding the stent providing a continued local anti-proliferative and anti-inflammatory effect for several months.
MiStent SES has been studied clinically in the DESSOLVE I and II trials. The first trial on 30 patients showed no reduction in artery lumen diameter between 8 and 18 months (late lumen loss of 0.09mm). The second trial of 184 patients, which compared MiStent SES and Medtronic Endeavor DES, showed lower MACE at three years in the MiStent SES arm (8.3% vs 15.3%, p=0.2), with a very low rate of re-intervention for MiStent SES (TLR of 2.5% at 3 years) and no definite or probable stent thrombosis.
MiStent SES has received CE marking and has not yet been marketed. STENTYS plans to launch the product in H1 2015 in Europe, to be followed by further geographies. STENTYS and Micell will partner to conduct MiStent’s post-market study, DESSOLVE III.