October 31, 2016 — Micell Technologies Inc. announced that it presented five-year clinical safety and efficacy results from the DESSOLVE I and II trials of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent). MiStent is designed to optimize vessel healing and long-term clinical performance in patients with coronary artery disease, and the presented data demonstrate sustained desirable clinical outcomes.
The results were presented at the 28th Annual Transcatheter Cardiovascular Therapeutics (TCT) conference, Oct. 29-Nov. 2 in Washington, D.C.
In a session titled "Emerging Bioresorbable Polymer-Based Metallic DES [drug-eluting stents]," five-year results were presented from the DESSOLVE I and II clinical studies, which demonstrated a combined (DES I and II) target lesion revascularization (TLR) rate of 2.7 percent at five years. No probable or definite stent thromboses were reported in either study through five-year follow-up. David E. Kandzari, M.D., director of interventional cardiology and interventional cardiology research for Piedmont Heart Institute of Atlanta, Ga., made the presentation.
Kandzari commented, "These results from DESSOLVE I and II validate our initial hypothesis that MiStent's unique pharmacokinetic profile, with a rapidly absorbing polymer and extended elution of crystalline sirolimus, permits faster and stable vessel healing that translates to exceptional long-term outcomes."
Dean J. Kereiakes, M.D., medical director of The Christ Hospital Heart & Vascular Center and The Lindner Research Center, Cincinnati, Ohio, also presented data on the five-year results in a poster session. Kereiakes concluded, "This pooled analysis of patients treated with MiStent, which has a linear drug release and ultra-thin-strut, cobalt chromium stent design, suggests excellent long-term safety and efficacy of this novel coronary stent."
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.
MiStent has received CE marking, but is not approved for sale in the United States.
For more information: www.tct.org/crf