Shanghai Easy-Flow Medical Tech Co., Ltd. ("Easy-Flow™") has completed patient enrollment for its pre-market clinical trial of the EF-Yangtze™ 14/18 Drug-Eluting Balloon Dilation Catheter ("EF-Yangtze™ DEB"), with Professor Lianrui Guo of the Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University serving as the Principal Investigator.

Launched in April 2023, this prospective, multicenter, randomized controlled trial aims to evaluate the safety and efficacy of the EF-Yangtze™ DEB in treating below-the-knee arterial stenosis or occlusive conditions. Participants were divided into two groups: one receiving the sirolimus-coated balloon (experimental group) and the other receiving the paclitaxel-coated balloon (control group). The primary endpoint is the six-month Target Lesion Primary Patency (TLPP) rate, with a two-year clinical follow-up for participants.

EF-Yangtze™ DEB utilizes sirolimus, recognized for its superior anti-restenosis and anti-inflammatory properties, and possesses a favorable safety dosage profile. To overcome the challenge posed by sirolimus's low lipid solubility—which impacts its absorption and retention in tissues—EF-Yangtze™ DEB applies a novel carrier-free recrystallization technology within its drug coating. This technology significantly improves the adhesion of sirolimus to the balloon surface.Upon dilation, sirolimus rapidly diffuses across the layers of the vessel, forming stable, needle-shaped crystals within the vessel wall that ensure a prolonged therapeutic effect. Preclinical studies have demonstrated that tissues treated with the EF-Yangtze™ DEB maintain effective drug concentrations for up to 180 days post-treatment.

Zhenghua Miao, Chairman and General Manager of Easy-Flow™, remarked on this pivotal achievement, noting, "In the field of below-the-knee (BTK) artery disease treatment, there is a growing but still limited body of clinical evidence supporting the use of drug-coated balloons. The successful completion of enrollment for our trial represents a significant milestone for Easy-Flow™. We are hopeful that the forthcoming results and comprehensive data from this study will yield essential insights for the treatment of BTK disease. Easy-Flow™ is dedicated to enhancing and expanding treatment options to markedly improve the lives of those suffering from vascular diseases."