ORION 12-Month Data Support Boston Scientific's Epic Stent for Iliac Artery Disease

October 23, 2012—Boston Scientific Corporation (Natick, MA) announced that 12-month clinical endpoint data from the ORION trial demonstrated the safety and effectiveness of the Epic self-expanding nitinol stent system in patients with obstructed iliac arteries. ORION Principal Investigator Daniel Clair, MD, presented the results at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida.

“Following the recent presentation of our 9-month data, the 12-month ORION data continue to show very strong clinical outcomes,” commented Dr. Clair in the company's press release. “The performance of the Epic stent in challenging iliac artery lesions and the long-term demonstration of both safety and efficacy of the Epic stent is another example of our ability to offer patients a durable treatment option for iliac artery disease.”

As summarized in Boston Scientific's press release, the prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. The trial previously met its primary endpoint of major adverse events (MAE) at 9 months with a rate of 3.4% for the Epic stent compared to a prespecified performance goal. Major adverse events are defined as death within 30 days, myocardial infarction (MI) occurring during hospitalization, target vessel revascularization (TVR) through 9 months and amputation of the treated limb through 9 months. The MAE rate at 12 months was 5.4%, with all MAEs related to TVR. No amputations were reported through the 12-month period.

Duplex ultrasound showed a primary patency of 94.4% at 12-month follow-up period. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. Patients experienced significant clinical improvement from baseline to 12 months based on feedback from validated questionnaires evaluating walking distance, speed, and stair climbing.

According to Boston Scientific, the Epic stent is a self-expanding nitinol stent designed to sustain vessel patency while providing enhanced visibility and accuracy during placement. The device's Tandem Architecture is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics across a variety of stent sizes. The Epic stent is compatible with 6-F sheaths, and the stent delivery system is compatible with .035-inch guidewires.

The ORION clinical data were used to support application for US Food and Drug Administration approval of the Epic nitinol stent system, which was launched in the United States in May 2012. The Epic system received CE Mark approval and was launched in Europe and other international markets in 2009, advised Boston Scientific.