Boston Scientific Corporation (NYSE: BSX) today announced that it has completed 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, a form of peripheral artery disease associated with severe leg pain caused by insufficient blood flow to the muscles (claudication). The trial will examine rates of device- and/or procedure-related major adverse events and patency rates at nine months in 125 patients at 28 sites in the United States.
"We are pleased to complete the enrollment phase of this important trial," said Daniel Clair, M.D., F.A.C.S., Chairman of the Department of Vascular Surgery, The Cleveland Clinic Foundation, and Principal Investigator of the trial. "Peripheral stenting has become a recognized standard in the treatment of iliac artery disease, and the ORION trial will provide important data on the performance of the EPIC Stent in treating these types of lesions."
The next-generation EPIC Stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. It employs an innovative Radial Tandem Architecture™, which is engineered to provide stent flexibility while maintaining 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 6F (2.1 mm) sheaths, and the stent delivery system is compatible with 0.035 inch (0.89 mm) guidewires.
"We are encouraged by the success of our EPIC Stent since its European approval and launch in early 2009, and we look forward to its approval in the U.S. based on results from this trial," said Joe Fitzgerald, Senior Vice President and President of Boston Scientific's Endovascular Unit. "The EPIC Stent is designed to offer a more balanced stent platform, allowing for excellent radial force without compromising stent flexibility and providing physicians a less-invasive alternative to surgery for treating iliac artery disease."
The EPIC Stent builds on Boston Scientific's long-time leadership in the peripheral intervention market. The Company's peripheral product lines feature technologies used to diagnose and treat peripheral artery disease, including stents, balloon catheters, sheaths, wires, peripheral embolization solutions and vena cava filters. This advanced product portfolio offers physicians a range of peripheral stent indications, including the Carotid WALLSTENT® Endoprosthesis for carotid artery disease and the Express® SD Stent for renal artery disease. Boston Scientific is the only company with a premounted balloon-expandable stent approved by the U.S. Food and Drug Administration for use in treating iliac artery disease -- the Express® LD Iliac Stent.
Iliac stenosis (narrowing) occurs when plaque accumulates within the arteries that supply blood to the legs, which can lead to poor blood flow, claudication and other complications. The disease can be treated with medication, surgery or angioplasty.
The EPIC Nitinol Stent System is an investigational device and is limited by applicable law to investigational use only and is not available for sale in the U.S.
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