Five-Year DESSOLVE Data Presented for Micell Technologies’ MiStent
November 7, 2016—Micell Technologies, Inc. announced 5-year clinical safety and efficacy results from the DESSOLVE I and DESSOLVE II trials of the company’s MiStent sirolimus-eluting absorbable polymer coronary stent system. David E. Kandzari, MD, presented the data at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium, which was held October 29 to November 2 in Washington, DC.
According to Micell Technologies, the data demonstrate sustained desirable clinical outcomes with the MiStent device, which is designed to optimize vessel healing and long-term clinical performance in patients with coronary artery disease. The 5-year results from the DESSOLVE I and II demonstrated a combined target lesion revascularization (TLR) rate of 2.7%. No probable or definite stent thromboses were reported in either study through 5-year follow-up.
The MiStent has received European CE Mark approval supported by clinical data from the DESSOLVE I and II studies that demonstrated superior in-stent late lumen loss rates and a favorable safety profile. The device is not approved for sale in the United States, advised the company.
In the company’s press release, Dr. 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.” Dr. Kandzari is Director of Interventional Cardiology and Interventional Cardiology Research at Piedmont Heart Institute of Atlanta, Georgia.
Dean J. Kereiakes, MD, who also presented data on the 5-year results in a poster session at TCT 2016, stated, “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.” Dr. Kereiakes is Medical Director of The Christ Hospital Heart & Vascular Center and The Lindner Research Center in Cincinnati, Ohio.