Micell Technologies has announced the preliminary data from the DESSOLVE I study of the MiStent Sirolimus drug-eluting coronary stent system.
MiStent features a proprietary stent coating that contains a crystalline drug (Sirolimus) and an absorbable polymer, designed to optimise healing in patients with coronary artery disease.
The DESSOLVE I trial treated 30 patients using angiography, IVUS and OCT after: four, six and eight months, and evaluated the safety and efficacy of the stent.
Preliminary data demonstrated a very low median in-stent late lumen loss of 0.03mm at four months, 0.1mm at six months and 0.08mm at eight months, with no binary restenosis or revascularisations.
Micell Technologies chief medical advisor Dennis Donohoe said the data from the DESSOLVE I trial demonstrate the importance of the MiStent design in enabling elimination of drug and polymer from the stent in 45 to 60 days.
The DESSOLVE II trial will assess the superiority of the MiStent in reducing in-stent late lumen loss at nine months, compared to Medtronic‘s Endeavor Sprint drug-eluting stent.
Principal investigator John Ormiston said that MiStent will provide enhanced patient safety and outcome by eliminating long-term exposure to non-erodible polymers.