Micell Technologies Announces First Patient Enrolled In Landmark Registration Trial of MiStent In Japan
DURHAM, N.C., Micell Technologies, Inc. (Micell) announced enrollment of the first patient in DESSOLVE J: a prospective, randomized, balanced, controlled, double-blind, multi-center study comparing MiStent SES® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent) to XIENCE V Everolimus Eluting Coronary Stent System (Xience) in Japan. Shigeru Saito, M.D., Vice Director, Shonan Kamakura General Hospital and Director of Cardiology and Catheterization Laboratories, is the principal investigator.
DESSOLVE J is an all-comers trial with a primary endpoint of target lesion failure (TLF) comparing 12-month clinical outcomes between MiStent and Xience. Candidates for trial participation suffer from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, acute coronary syndromes and those who qualify for percutaneous coronary interventions. Enrollment is planned at approximately 10 clinical sites throughout Japan.
“We are pleased to enroll the first patient in this important study,” said Dr. Saito. “This study is a historic one for Japan. It will provide us with valuable insights into the potential benefits of MiStent’s unique pharmacokinetic profile, with a rapidly absorbing polymer and extended elution of crystalline sirolimus.”
DESSOLVE J is intended to provide Japanese-specific data that is supportive of DESSOLVE III, an all-comers clinical study that includes 1,400 patients randomized to MiStent or Xience at 20 sites in Europe. DESSOLVE III completed enrollment in 2015. Following the completion of DESSOLVE J, Micell intends to file a pre-market approval application with Japan’s Pharmaceuticals and Medical Devices Agency for approval by its Ministry of Health, Labour, and Welfare.
Micell’s patented supercritical fluid technology allows for a rigorously controlled coating of the drug and polymer, whereby the drug is applied to a bare-metal stent in a dry powder, crystalline form. This preserves its morphology and optimizes its pharmacokinetic (distribution and absorption) profile. MiStent also leverages the benefits of a cobalt chromium coronary stent system -- a state-of-the-art, ultra-thin-strut metallic stent that has demonstrated excellent deliverability, conformability and flexibility.
Arthur J. Benvenuto, Chairman and Chief Executive Officer of Micell said, “Cardiovascular disease poses a significant health risk in Japan and even with recent improvements in coronary artery disease treatment, additional advances in drug-eluting stents are still needed. Studies of MiStent to date have demonstrated a desirable lack of late lumen loss over 18 months, a characteristic that makes MiStent a clinically meaningful improvement that could provide clinicians and patients worldwide with enhanced treatment options.”
Micell Technologies, Inc.