Boston Scientific has presented the positive results from the nine-month Orion trial, evaluating its Epic self-expanding nitinol stent system in patients with iliac artery disease, a form of peripheral artery disease associated with severe leg pain caused by insufficient blood flow.
The Epic stent is a self-expanding nitinol stent that incorporates Tandem Architecture to provide stent flexibility, while maintaining predictable radial force characteristics across the entire stent size matrix.
The prospective single-arm Orion trial enrolled 125 patients and demonstrated that the trial met its primary endpoint, a composite rate of device and/or procedure-related major adverse events (MAE) at nine months. In the study, the stent showed a low nine-month MAE rate of 3.4% in the intent-to-treat population, which was considerably lower than the pre-specified performance goal of 17% based on historical published outcomes for iliac stenting.
Principal investigator of the trial Daniel Clair said the results from the Orion trial supported both the safety and efficacy of the Epic stent and confirmed its efficacy in the treatment of atherosclerotic lesions in iliac arteries. "Peripheral stenting has become a recognised standard in the treatment of iliac arterial disease to restore blood flow in blocked leg arteries," he added.
Patients implanted with the Epic stent experienced clinical improvement from baseline to nine months, and also showed improvement in the patient population from 7.2% being asymptomatic or having mild claudication at baseline to 82.3% of patients at 30 days and 81.6% at nine months.
Boston Scientific Peripheral Interventions business president Jeff Mirviss said the Epic stent is a novel stent platform, intended to provide both acute and clinical advantages over older-generation stent systems. ''Upon approval, the Epic stent along with the market-leading Express LD balloon-expandable iliac stent would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients,'' he said.
The company submits the Orion clinical data to the US Food and Drug Administration (FDA) to attain marketing approval for the Epic stent system.
Image: A stent is an artificial tube inserted into a natural passage or conduit in the body to prevent or counteract a disease-induced, localised flow constriction.