The MiStent® SES is a CE marked drug-eluting stent that has been designed to optimize healing. The Company's rapid-absorbing drug/polymer formulation is intended to precisely and consistently control drug elution and the duration of polymer exposure. As a result, the MiStent SES is intended to deliver a precise therapeutic solution for coronary artery disease with the potential to avoid the long-term safety concerns associated with current drug-eluting stents integrating durable polymers.
Using an approved drug (sirolimus, also known as rapamycin) and a bioabsorbable polymer (PLGA), Micell's patented supercritical fluid technology allows a carefully controlled drug/polymer coating to be applied to a bare metal stent. Micell is leveraging the strengths of EuroCor's Genius MAGICŪ Cobalt Chromium Coronary Stent System, a state-of-the-art CE marked bare metal stent, shown to demonstrate excellent deliverability, conformability and flexibility. In GLP pre-clinical trials, the coating is eliminated from the stent in 45 to 60 days in vivo, resulting in a bare metal stent*.
* Based on animal data. Clinical significance in humans is unknown.