Boston Scientific announced on 10 January 2011 that it has completed enrolment 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. 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 USA.
“We are pleased to complete the enrolment phase of this important trial,” said Daniel Clair, chairman of the department of Vascular Surgery, The Cleveland Clinic Foundation, and principal investigator of the trial. “Peripheral stenting has become a recognised 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,” explained Clair.
The next-generation Epic stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. The ORION trial incorporates stent diameter ranges from six to 12mm and lengths up to 120mm. All stent sizes are compatible with 6F (2.1mm) sheaths, and the stent delivery system is compatible with 0.035 inch (0.89mm) 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 USA based on results from this trial,” said Joe Fitzgerald, senior vice president and president of Boston Scientific’s Endovascular Unit.
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 USA.