Shanghai Easy-Flow Medical Tech Co., Ltd. ("Easy-Flow™")  has recently launched a prospective, multi-center, randomized controlled clinical study to examine the safety and efficacy of EF-Don™ Drug Coated Hemodialysis Shunt Balloon Dilation Catheter ("EF-Don™ DCB") for the treatment of arteriovenous fistulae ("AVF") stenosis in patients undergoing hemodialysis.

Led by principal investigators Prof. Yaxue SHI of LongHua Hospital Shanghai University of Traditional Chinese Medicine, and Prof. Yu ZHAO of The First Affiliated Hospital of Chongqing Medical University, the study will recruit more than 200 participants in China, and the first 4 volunteers have been recently enrolled in LongHua Hospital Shanghai University of Traditional Chinese Medicine.

According to the data presented at 2022 Annual Conference of Chinese Nephrologist Association, more than 700,000 Chinese have end-stage renal disease ("ESRD") and require life sustaining dialysis treatments in China. The arteriovenous fistula ("AVF") , considered as the most ideal type of vascular access for hemodialysis, is frequently complicated by dysfunction due to stenosis or occlusion. In China, percutaneous transluminal balloon angioplasty ("PTA"), typically with high-pressure balloons, is the first line treatment for stenosis. However, PTA is associated with high rates of reintervention secondary to restenosis. Paclitaxel-coated balloons have been proven to be safe and effective in the peripheral artery disease by reducing neointimal hyperplasia–causing restenosis, and thus may offer a potential solution in the landscape of treatment for AVF stenosis.

EF-Don™ DCB is designed to deliver paclitaxel coated on the surface of the high-pressure balloon, enabling a better dilation of the treated hemodialysis access lesions, paired with transferring the drug into the vessel wall to inhibit restenosis, which can be expected to achieve a longer-term patency and reduction in reinterventions, thereby with a result of lower economic burden.

"We are pleased to launch EF-Don™ DCB clinical trial,” said Zhenghua MIAO, Chairman and General Manager of Easy-Flow™. "It is a new step forward for Easy-Flow™ following the clinical trial of EF-Yangtze™ sirolimus drug eluting balloon in the treatment of below-the-knee artery disease earlier this year. We are eager to advance the study with the goal of bringing a new treatment option for people living with hemodialysis vascular access stenosis."