Boston Scientific Corporation announced the start of patient 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 that impacts a patient's lower extremities. The first U.S. patient was enrolled on May 14 by Nicolas W. Shammas, M.D., at Trinity Terrace Park Hospital in Bettendorf, Iowa.
"Peripheral stenting has become a recognized standard in the treatment of iliac arterial disease," said Daniel Clair, M.D., FACS, Principal Investigator of the trial and Chairman of the Department of Vascular Surgery, The Cleveland Clinic Foundation. "The ORION clinical trial will provide important data on the performance of the EPIC Stent in the treatment of atherosclerotic lesions in iliac arteries."
"We are encouraged by the early positive response to our EPIC Stent in Europe, where it was launched last month, and we are pleased to begin the process of evaluating it for use in the United States," said Donald S. Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. "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 new option for treating iliac disease."
The EPIC Stent is a self-expanding nitinol stent designed to sustain vessel patency (openness), while providing enhanced visibility during placement. The ORION trial incorporates stent diameter ranges from 6-12 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'' (0.89 mm) guidewires.
The trial will enroll 123 patients at 25 sites in the U.S. and will examine rates of device- and/or procedure-related major adverse events (MAE) at nine months. MAE are currently defined as death within 30 days, myocardial infarction (MI, or heart attack) occurring during related hospitalization, target vessel revascularization (TVR) through nine months and amputation of the treated limb through nine months.
The EPIC Stent is a next-generation product that builds on Boston Scientific's long-time leadership in the peripheral interventions market. The Company's peripheral product lines feature technologies used to diagnose and treat peripheral 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.
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.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.