Micell Technologies has enrolled at Mercy Hospital in Auckland, New Zealand, the first patient in DESSOLVE I (DES with Sirolimus and a bioabsorbable pOLymer for the treatment of patients with de noVo lEsions in the native coronary arteries), a first-in-human clinical trial of the company's investigational MiStent Drug Eluting Coronary Stent System (MiStent DES).
The DESSOLVE I study 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.
The study uses multiple imaging modalities to better understand the time to complete tissue coverage of the stent struts relative to polymer absorption.
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, designed to optimize dosing of the drug throughout the affected artery.
In pre-clinical trials, the drug completely elutes and the polymer is eliminated within 90 days in vivo resulting in a bare metal stent.
Micell chairman and CEO Arthur Benvenuto said that they designed the MiStent DES to bring together the clinical advantages of a drug-eluting stent with the long-term safety and stability of a bare metal stent and said that their supercritical fluid technology enables them to develop a drug-eluting stent with precise and consistent dissolution kinetics that can be adjusted for a specific requirement.