Nov. 14, 2014 — Micell Technologies Inc. announced commercialization plans for its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES). In support of this strategy, the company has entered into a five-year agreement with Stentys as an exclusive worldwide distributor of the MiStent SES, except in the United States, Canada, China, South Korea and Japan. Stentys plans to launch MiStent in the first half of 2015 in Europe, followed by many other geographies where they have built a commercial network.
Dennis Donohoe, M.D., Micell's chief medical advisor, added, "We hear from physicians that they need the innovation MiStent SES offers as the only bioabsorbable coated DES to sustain local drug delivery beyond the presence of the polymer. MiStent provides therapeutic drug levels of sirolimus in the tissue surrounding the stent for up to nine months. The polymer is eliminated by three months without the loss of anti-restenotic drug effects, which differentiates MiStent from any other DES formulation."
In addition to the distribution partnership, Micell will work closely with Stentys to perform a post-market study, DESSOLVE III. This study will be a prospective, multi-center, balanced randomized controlled study enrolling approximately 1,400 subjects at up to 20 study centers. Subjects will be followed for a total of three years with a primary endpoint of Target Lesion Failure (TLF) at 12 months follow up. There will also be an OCT sub-study that will evaluate the progression of neointimal volume over two years follow-up.
About the MiStent SES
The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of the MiStent SES is intended to precisely and consistently control drug elution and limit the duration of polymer exposure, thereby potentially reducing the safety risks associated with current commercially available drug-eluting stent technologies. The innovative MiStent SES system includes a proprietary stent coating that contains crystalline drug (sirolimus) and an absorbable polymer. The 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.
Using an approved drug (sirolimus) and polymer (PLGA), Micell's patented supercritical fluid technology allows a rigorously controlled drug/polymer coating to be applied to a bare-metal stent. The MiStent SES leverages the benefits of a cobalt chromium coronary stent system, a state-of-the-art thin-strut bare-metal stent, which has demonstrated excellent deliverability, conformability and flexibility.
Results of animal studies have determined that the coating is cleared from the stent in 45 to 60 days leaving a bare-metal stent, and the polymer is completely absorbed into the surrounding tissue within 90 days to promote long-term patency and compatibility with the artery.
Micell was granted CE (Conformite Europeenne) mark approval for MiStent SES for the European Economic Union but is not approved in the United States or any other country. The three-year follow-up of DESSOLVE I and II clinical studies subjects was completed in 2014 and these patients continue to undergo long-term follow-up.
About DESSOLVE I and DESSOLVE II Studies
The DESSOLVE I trial, the first clinical assessment of safety and efficacy of the MiStent SES, treated 30 patients with de novo lesions in coronary arteries ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 23 mm length stent. Subjects were enrolled across five study centers in New Zealand, Australia and Belgium. Three independent subgroups of 10 patients each were evaluated using angiography, IVUS and OCT at three time points: four, six and eight months. The primary efficacy endpoint was in-stent late lumen loss. Safety was assessed by incidence of MACE and presence of strut coverage with tissue within the treated artery at each time point. William Wijns, M.D., Ph.D., Cardiovascular Center, Aalst, Belgium and John Ormiston, M.B.Ch.B., Mercy Angiography Unit, Auckland, New Zealand are co-principal investigators for this trial. Imaging results demonstrated no progression of late lumen loss beyond 6/8 months and at three years, MACE was 6.9% due to two non-target vessel MI, TLF was 0% and TLR was 0%.
The DESSOLVE II CE (Conformite Europeenne) Mark trial is a randomized, multi-center study of patients with documented stable or unstable angina pectoris. The primary endpoint is superiority of the MiStent SES in minimizing in-stent late lumen loss at nine months, compared to Medtronic's Endeavor® Sprint DES, as measured by an independent angiography core laboratory in de novo coronary lesions in vessels ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 30 mm length stent. The DESSOLVE II study completed enrollment of 184 patients in July 2011. Data analysis confirms that DESSOLVE II met all study objectives, demonstrated a competitive in-stent late lumen loss and achieved a strong signal of safety. At three years, MACE was 8.3%, TLF was 5.8% and TLR was 2.5%.
For more information: www.stentys.com