It’s TCT2013 week, so expect a few announcements like this one from Micell Technologies, Inc. The company is pointing to 2 year results from trials of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®, which it says supports the principle that sustained presence of the eluting drug is beneficial in preventing late lumen loss.
The MiStent SES is a thin-strut drug-eluting stent, distinguished by a rapidly absorbable coating designed to control drug release, and which Micell says was developed to optimize vessel healing in patients with coronary artery disease. The device gained CE Mark approval in June 2013, but is not approved in the United States or any other countries.
The innovative MiStent SES system includes a proprietary stent coating that contains crystalline drug (sirolimus) and an absorbable polymer. The stent coating provides controlled and sustained release of therapeutic levels of drug as the polymer softens and disperses from the stent into the adjacent tissue. These properties are intended to enhance safety as compared to conventional permanent polymer DES.
Data from the so-tagged DESSOLVE I and DESSOLVE II trials of MiStent SES were presented at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference held in San Francisco. “MiStent: 2-year Randomized Trial Results from a Sirolimus-eluting Stent with a Bioabsorbable Coating,” was part of the Scientific Symposium, “Next Generation DES and Bioabsorbable Scaffolds” conducted on Sunday, October 27 by John Ormiston, M.B.Ch.B., Interventional Cardiologist with the Mercy Angiography Unit, Auckland, New Zealand.
The DESSOLVE I trial demonstrated minimal progression of late lumen loss between eight and 18 months follow up, with no target lesion MACE events through two years. The DESSOLVE II randomized trial two-year MACE rate was 6.7% for MiStent and 13.3% for Endeavor DES control group. There were no probable or definite stent thromboses related to MiStent use in either trial through two years. Detailed IVUS, angiographic and OCT imaging with endothelial function testing conducted across the two trials demonstrated bare-metal stent type healing with maintenance of normal endothelial function.
Principal study investigator Dr. Ormiston commented, “MiStent is the only product in its class to optimize local drug delivery properties by providing up to nine months of drug presence with only three months for polymer absorption. Because the drug persists three times longer than the polymer, MiStent eliminates the inflammatory effect of the polymer quickly and retains the anti-inflammatory and anti-restenotic drug six months beyond the presence of the polymer.”
Dennis Donohoe, M.D., Micell’s Chief Medical Advisor, added, “We were very pleased with the two-year clinical findings in DESSOLVE I and II and specifically with respect to the unique finding of a lack of progression of late lumen loss over an 18 month period, in conjunction with excellent tissue healing as shown through detailed clinical imaging.”
Source: Micell Technologies, Inc., PR Newswire