Micell Technologies' MiStent SES Could Benefit Patients with Coronary Artery Disease

Unique safety profile could benefit patients with coronary artery disease

 

July 12, 2013

Micell Technologies Inc.'s thin-strut stent features elimination of the coating from the stent in 45-60 days and the complete absorption of the polymer coating within 90 days. The MiStent sirolimus-eluting absorbable polymer coronary stent system (MiStent SES) is unique in providing local drug delivery both during and after the period of polymer absorption, thereby eliminating long-term polymer exposure, a potential cause of delayed healing and late adverse events.

The MiStent SES approval is supported by in-depth clinical analysis from the DESSOLVE I and DESSOLVE II clinical trials. The DESSOLVE II trial met its primary endpoint: superiority of MiStent SES in minimizing in-stent late lumen loss (LLL) at nine months as compared to Medtronic's Endeavor Sprint DES (p<0.001). The trial was a randomized, multicenter study of 184 patients with documented stable or unstable angina pectoris. At nine months' follow-up, in-stent LLL was 0.27 mm with a target lesion revascularization rate of 0.9 percent. The major adverse cardiac events (MACE) rates were 4.3 percent for MiStent SES and 6.7 percent for Endeavor. In a subgroup of patients, optical coherence tomography (OCT) and endothelial function testing confirmed good vessel healing with excellent strut coverage and normal endothelial function.

The DESSOLVE I first-in-human study provides additional evidence for the potential clinical advantages of MiStent SES's unique features, as indicated by serial angiographic, intravascular ultrasound (IVUS) and OCT assessment of patients at early (6/8 month) and late (18 month) time points. Data analysis of the groups using matched pairs shows no progression of LLL (0.10/0.09 mm and 0.09 mm respectively). 

Micell received CE mark approval for the MiStent SES in June 2013.

For more information: www.micell.com

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