China-based Acotec Scientific Holdings Ltd (HKG: 6669) announced that its AcoArt Orchid & Dhalia DCB, a drug-coated balloon (DCB) product, has received indication expansion approval in China for use in autologous arteriovenous fistula (AVF) percutaneous transluminal angioplasty (PTA) in hemodialysis patients. The approval marks the product as the first of its kind in the country.
Product Profile
The AcoArt Orchid & Dhalia DCB is designed to inhibit intimal hyperplasia, improve vessel patency, and address AVF stenosis, thereby prolonging the usability of AVF access and extending patient lifelines. AVF is the mainstream hemodialysis access method for long-term patients, as kidney transplantation remains limited due to various factors.
Market Context
Hemodialysis is the preferred treatment for most end-stage renal failure patients. Previously, C.R. Bard and Medtronic’s DCB products received indication expansion approvals for AVF stenosis in the US, highlighting the global need for effective AVF management solutions.-Fineline Info & Tech
