InspireMD has reported positive six-month results from the MGuard coronary stent, first-in-man, multi-center ongoing trial in Germany.
The study’s goal is to establish the safety and efficacy of MGuard stent in high risk patients with complex lesions, according to the Tel Aviv, Israel-based InspireMD.
The company said the study’s primary end point demonstrated no major adverse cardiac events (MACE) after 30 days in 60 patients, with 100 percent procedural success rate. Following the results, the company released the six-month data of the first 30 patients, which demonstrated no stent thrombosis and low overall MACE rate of 6.6 percent (two target lesion revascularization cases in 30 patients).
The data also highlight the efficacy of MGuard in maintaining blood flow through the treated vessel after six months, InspireMD said. The late loss, a measurement of the reduced vessel diameter, was 0.38 mm and the restenosis rate was 6.6 percent.
The MGuard stent presents a combination of a coronary stent merged with an embolic protection device. It has also received CE Mark to treat patients with coronary artery diseases.