IDev starts self-expanding stent trial
This article was originally published in Clinica
IDev Technologies has enrolled the first patient in a trial of its self-expanding Supera stent. The 258-patient SUPERB study aims to demonstrate the safety and efficacy of the device in the treatment of obstructive arterial disease in the superficial femoral artery. The US FDA granted 510(k) clearance for Supera in August 2006 for the palliative treatment of biliary strictures caused by malignant neoplasms. Houston, Texas-based IDev also CE marked the stent for sale in Europe in May 2006 for biliary and peripheral vascular indications. Peripheral arterial disease of the lower extremities affects approximately 8-12 million people in the US, according to the American Heart Association.