Micell Technologies has completed patient enrollment for its Dessolve II clinical study for its MiStent Drug-Eluting Coronary Stent (DES) System.
Across 26 study centers throughout Europe and New Zealand 183 patients with documented stable or unstable angina pectoris have been enrolled in a five month period.
The MiStent DES is an ultra-thin drug-eluting stent with a rapid-absorbing drug or polymer coating formulation designed to optimize healing in patients with coronary artery disease.
The primary endpoint for the study is superiority of the MiStent DES in minimising in-stent late lumen loss at nine months compared to Medtronic’s Endeavor Sprint DES.
Micell Technologies chairman and CEO Arthur Benvenuto said the coating on the MiStent DES is designed to clear the stent within 45 to 60 days, provide controlled and sustained delivery of sirolimus for months, and limit vascular exposure to polymer coating to less than 90 days.
"As a result, we expect the MiStent DES could optimize sirolimus therapy by reducing the risk of complications such as late stent thrombosis, while suppressing neointimal hyperplasia and related healing responses to arterial injury that lead to restenosis," Benvenuto said.