Durham, NC-based Micell Technologies has enrolled the first patient in DESSOLVE I, a first-in-human clinical trial of the company's investigational MiStent drug-eluting coronary stent system.
DESSOLVE I is a prospective, open-label, non-randomized, single-arm study that is expected to enroll 30 patients at five clinical sites in Belgium, Australia and New Zealand. Candidates for the trial are patients with documented stable or unstable angina pectoris or ischemia.
The MiStent DES employs Micell's proprietary supercritical fluid technology that applies a precisely controlled bioabsorbable polymer--active drug (sirolimus) matrix onto a cobalt-chromium stent. The polymer dissolves and releases the drug into the surrounding tissue in a controlled manner. In preclinical trials, the drug completely elutes and the polymer is eliminated within 90 days in vivo resulting in a bare metal stent.
"The MiStent DES is designed to maintain the polymer-drug matrix on the stent only as long as drug delivery is required," says John Ormiston, Mercy Hospital, Auckland, New Zealand, and co-principal investigator. "It slowly reverts to a bare-metal stent by the time that drug treatment is completed. These are exactly the properties that interventional cardiologists are looking for in a drug-eluting stent."
- get the Micell release