Shanghai Easy-Flow Medical Tech Co., Ltd. ("Easy-Flow™ ") has recently announced the initiation of the pre-market clinical trial with its in-house developed EF-Yangtze™ 14/18 Drug Eluting Balloon Dilation Catheter (“EF-Yangtze™ DEB”) and begun the recruitment in Xuan Wu Hospital of the Capital Medical University, Dongzhimen Hospital of Beijing University of Chinese Medicine, and the First Affiliated Hospital of Chongqing Medical University.

This prospective, multi-center, randomized controlled clinical study, led by Principal Investigator Prof. Lianrui GUO, Department of Vascular Surgery, Xuanwu Hospital of the Capital Medical University, is designed to evaluate the safety and effectiveness of EF-Yangtze™ DEB for the treatment of stenosis or occlusion in the below the knee arteries. It is expected that more than 200 patients will be enrolled and randomly assigned to the sirolimus DEB group (experimental group) or paclitaxel DEB group (control group) with the ratio of 1:1.

In recent years, treatment with DEB has become a widely accepted option for peripheral arterial disease (PAD). Currently commercially available DEBs mostly use the cytotoxic paclitaxel as the anti-proliferative drug. However, with the safety concerns on paclitaxel in the endovascular surgery community, sirolimus DEB has been proposed as an alternative choice. Furthermore, sirolimus devices have already been widely used in the treatment of coronary arterial disease (CAD), demonstrating safety and efficacy in reducing restenosis in the long term. 

EF-Yangtze™ DEB is a sirolimus drug eluting balloon. Its unique coating technology enables efficient drug transfer into arterial tissue and sustained release in the long term. In vivo data shows that the therapeutic concentration level of sirolimus can be maintained in the tissues up to 90 days.

“We are excited to initiate our first clinical trial and this milestone paves the way to our goal to deliver a complete innovative minimally-invasive portfolio for the treatment of vascular diseases, ” said Zhenghua MIAO, Chairman and General Manager of Easy-Flow™. “We believe EF-Yangtze™ DEB will potentially offer a promising new option to the below-the-knee arterial disease with stenosis or occlusion and we will continue our efforts in the rapid enrollment process to gain enough clinical validation. In parallel, we are working on expanding our portfolio with the aim to offering more treatment solutions to benefit patients with vascular diseases.