Epic Nitinol Stent success in ORION trial for Iliac Artery Disease

The 125 patient ORION trial of the Epic self-expanding nitinol stent system for Iliac Artery Disease from Boston Scientific, met its primary endpoint, a composite rate of major adverse events (MAE)--including myocardial infarction, target vessel revascularization and amputation--at 9 months. The results exceeded expectations, demonstrating a 9-month MAE rate of 3.4% in the intent-to-treat population--far lower than the goal of 17%. The Epic Nitinol Stent already has a CE mark and Boston Scientific plan to use the ORION study results as the basis for its submission to the FDA.