Boston starts EPIC new stent trial
This article was originally published in Clinica
Executive Summary
Boston Scientific has begun a trial of its next-generation EPIC self-expanding nitinol stent system in patients with iliac artery disease. In the disorder, a patient's iliac arteries, which carry blood to the legs, become blocked. The ORION study will enrol 123 patients at 25 US sites, and will measure rates of device- and/or procedure-related major adverse events at nine months. These events are death within 30 days, myocardial infarction occurring during related hospitalisation, target vessel revascularisation, and amputation of the treated limb. The trial will incorporate stent diameter ranges of 6-12mm and lengths up to 120mm. Natick Massachusetts-based Boston launched EPIC in Europe last month, but it is not approved in the US.