Boston Scientific Completes Enrollment in ORION Trial of Epic Stent to Treat Iliac Disease

January 10, 2011—Boston Scientific Corporation (Natick, MA) announced the completion of enrollment in the ORION clinical trial, which is designed to evaluate the company's Epic self-expanding nitinol stent system for the treatment of iliac artery disease. The trial will examine rates of device- and/or procedure-related major adverse events and patency rates at 9 months in 125 patients at 28 sites in the United States. Daniel Clair, MD, is the principal investigator of the trial.

According to Boston Scientific, the Epic stent is designed to sustain vessel patency while providing enhanced visibility and accuracy during placement. The device employs the company's Radial Tandem Architecture, which is engineered to provide stent flexibility as it maintains predictable radial force characteristics across the entire stent size matrix. The ORION trial incorporates stent diameter ranges from 6 to 12 mm and lengths up to 120 mm. All stent sizes are compatible with 6-F sheaths, and the stent delivery system is compatible with 0.035-inch guidewires.

The company advised that in the United States, the Epic nitinol stent system is an investigational device and is limited by applicable law to investigational use only; it is not available for sale. In Europe, the Epic stent was approved and launched in early 2009.