Four-Year Data from DESSOLVE Trials Presented for Micell's MiStent

October 13, 2015—Micell Technologies, Inc. announced that 4-year clinical results from the DESSOLVE I and DESSOLVE II trials of the company’s MiStent sirolimus-eluting absorbable polymer coronary stent system (MiStent SES) were presented by Alexandra Lansky, MD, at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium being held October 11–15 in San Francisco, California.

According to the company, the data presented at TCT demonstrated both sustained and desirable long-term clinical and safety outcomes with the MiStent SES, which was designed to optimize vessel healing in patients with coronary artery disease.

The data included no target lesion events in the DESSOLVE I study and sustained clinical outcomes in both DESSOLVE I and DESSOLVE II through 4-year follow-up. There have been no probable or definite stent thromboses in either study. 

The MiStent SES also showed a low combined target lesion revascularization (TLR) rate for DESSOLVE I and II of 2.7% at 4-year follow-up, which is consistent with previously demonstrated lack of late loss progression in the DESSOLVE I study.

In the company’s press release, Dr. Lansky commented, “A key advantage that appears to be conferred by MiStent SES is sustained local drug delivery beyond the presence of the polymer. That’s exciting to me as a clinician because it means MiStent may provide therapeutic sirolimus levels in the tissue around the stent for up to 9 months, while limiting the duration of that patient’s exposure to polymer. Currently, there is no approved drug-eluting stent that provides full elimination of the polymer by 3 months without concomitant loss of antirestenotic drug effects.” Dr. Lansky is Director of Interventional Cardiovascular Research at Yale University School of Medicine in New Haven, Connecticut.

The European Union’s approval of MiStent SES was supported by clinical data from the DESSOLVE I and II trials. MiStent SES is not approved by the US Food and Drug Administration for sale or use in the United States.