FDA clears IDev's biliary stent delivery system
This article was originally published in Clinica
IDev Technologies' Supera Veritas transhepatic biliary system has received 510(k) clearance from the US FDA. The product is a next-generation delivery system for the firm's Supera biliary stent, which has been available in the US since 2006 for the palliative treatment of obstructions in the bile duct caused by malignant neoplasms. Supera Veritas makes deploying the stent easier and more precise, Webster, Texas-based IDev says. The firm plans to launch the delivery system in the first quarter of next year. Supera Veritas is also being evaluated along with the Supera stent in an ongoing US trial in patients with peripheral arterial disease of the superficial femoral artery.