Nine-Month ORION Data Support Boston Scientific's Epic Stent to Treat Iliac Disease

January 16, 2012—Boston Scientific Corporation (Natick, MA) announced that Principal Investigator Daniel Clair, MD, presented 9-month clinical endpoint data from the company's ORION trial at the International Symposium on Endovascular Therapy (ISET) in Miami Beach, Florida. The ORION trial is evaluating the Epic self-expanding nitinol stent system in patients with iliac artery disease.

According to the company, the prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. The trial met its primary endpoint, which is a composite rate of device- and/or procedure-related major adverse events (MAE) at 9 months. MAE are defined as death within 30 days, myocardial infarction occurring during hospitalization, target vessel revascularization through 9 months, and amputation of the treated limb through 9 months.

At ISET, Dr. Clair reported that the Epic stent demonstrated a 9-month MAE rate of 3.4% in the intent-to-treat population, which was significantly lower than the prespecified performance goal of 17% (P < .001) based on historical published outcomes for iliac stenting. All reported MAE were related to target vessel revascularization. No deaths through 30 days and no amputations through 9 months were observed.

Additionally, patients experienced significant clinical improvement from baseline to 9 months based on feedback from validated questionnaires evaluating walking distance, speed, and stair climbing. An additional measure of effectiveness based on the Rutherford classification showed improvement in the patient population from 7.2% being asymptomatic or having mild claudication (class 0–1) at baseline to 82.3% of patients at 30 days and 81.6% at 9 months. Duplex ultrasound showed a primary patency rate of 95.9%, primary assisted patency of 96.7%, and secondary patency of 98.3%, indicating that treated lesions remained open through the 9-month follow-up period.

“Peripheral stenting has become a recognized standard in the treatment of iliac arterial disease to restore blood flow in blocked leg arteries,” commented Dr. Clair. “Outcomes from the ORION trial support both the safety and efficacy of the Epic stent and confirm its excellent performance in the treatment of atherosclerotic lesions in iliac arteries.”

Boston Scientific advised that the ORION clinical data are being used to support the application for US Food and Drug Administration approval of the Epic stent system, which was submitted to the agency in September 2011. In the United States, the Epic device is an investigational device limited by applicable law to investigational use only and not available for sale. The device received CE Mark approval and was launched in Europe and other international markets in 2009.