Bioresorbable MiStent DES Demonstrates Lack of Late Lumen Loss Two-Years

 

March 12, 2014

March 12, 2014 — Micell Technologies Inc. announced that imaging and clinical results from the DESSOLVE I and DESSOLVE II trials of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) were presented at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference held last fall. The MiStent SES is a thin-strut drug-eluting stent distinguished by a rapidly absorbable coating designed to control drug release, and which was developed to optimize vessel healing in patients with coronary artery disease.

The data presentation, "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." John Ormiston, M.B.Ch.B., interventional cardiologist with the Mercy Angiography Unit, Auckland, New Zealand presented the data. Ormiston is a principal investigator in the DESSOLVE studies.

Two-year follow-up data from the DESSOLVE I and II trials were presented. 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.

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."

Data featured at TCT recently were included in a peer-reviewed paper published by JACC Cardiovascular Interventions: "First-in-Human Evaluation of a Bioabsorbable Polymer–Coated Sirolimus–Eluting Stent: Imaging and Clinical Results of the DESSOLVE I Trial (DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesion in the Native Coronary Arteries)". Authors of this paper included co-principal investigators for the DESSOLVE I trial, William Wijns, M.D., Ph.D., of the Cardiovascular Center, Aalst, Belgium and John Ormiston, M.B.Ch.B., of the Mercy Angiography Unit, Auckland, New Zealand.

For more information: www.micell.com