Boston Scientific has presented Epic Self-Expanding Nitinol Stent System's nine-month clinical endpoint data from its ORION trial.
The prospective, single-arm trial, which enrolled 125 patients, was designed to assess the safety and efficacy of Epic Stent in the treatment of atherosclerotic lesions in iliac arteries.
The study met its primary endpoint with a composite rate of device- and/or procedure-related major adverse events (MAE) at nine months.
The study also observed with no deaths through 30 days and no amputations through nine months.
The Epic Stent is comprised with a tandem architecture which provides excellent stent flexibility and also maintains predictable radial force characteristics across the entire stent size matrix.
The stent also sustains vessel patency, while providing enhanced visibility and accuracy during placement.
The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires.
Boston said the ORION clinical data of the Epic Stent system is being used to support application for US Food and Drug Administration (FDA) approval.