FDA approves IDE trial for Urotronic ’s drug-coated balloon

Minneapolis-based Urotronic said this week that the FDA approved an investigational device exemption trial for its Optilume drug-coated balloon catheter, which is designed to treat urethral strictures in men. The 200-patient pivotal trial is slated to start enrolling participants immediately. Get the full story at our sister site, Drug Delivery Business News. The post FDA approves IDE trial for Urotronic’s drug-coated balloon appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Urology Vascular urotronic Source Type: news