Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received Investigational Device Exemption (IDE) approval from the U.S. FDA for its AcoArt Litos paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This IDE approval enables Acotec to commence clinical trials for the device, pending Institutional Review Board (IRB) clearance.
The AcoArt Litos is designed to prevent below-the-knee (BTK) artery stenosis or occlusion and to treat chronic limb ischemia through vascular intervention. The device has previously secured CE marks, breakthrough device designation, and marketing approvals in the European Union, U.S., and China in 2014, 2019, and 2020, respectively, underscoring its established presence in the global market.- Flcube.com
