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InspireMD Has Positive Efficacy and Safety Results for Stent

May 5, 2008

InspireMD has achieved positive results with its MGuard coronary stent in an ongoing multicenter trial in Germany.

This first-in-human study aims at establishing the safety and efficacy of the product in high-risk patients with complex lesions.

The study’s primary endpoint demonstrates 0 percent major adverse cardiac events (MACE) after 30 days in 60 patients with a 100 percent procedural success rate. Following these results, the company released the six-month data of the first 30 patients. These data demonstrate no thrombosis and an overall MACE rate of 6.6 percent. The data also highlight the efficacy of MGuard in maintaining blood flow through the treated vessel after six months, according to the company.

The product combines a coronary stent with an embolic protection device. It has received a CE Marking to treat patients with coronary artery diseases.