Shanghai Easy-Flow Medical Tech Co., Ltd. ("Easy-Flow™") has officially initiated the clinical trial for the EF-Lumber™ peripheral drug-eluting stent, with the first patient enrolled by Professor Dai Xiangchen and his team from Tianjin Medical University General Hospital.

This prospective, multi-center, randomized controlled trial aims to evaluate the safety and efficacy of the peripheral drug-eluting stent for treating stenosis or occlusion in the superficial femoral artery. Professor Dai Xiangchen from Tianjin Medical University General Hospital and Professor Guo Lianrui from Xuanwu Hospital, Capital Medical University serve as the principal investigators.

Superficial femoral artery occlusive disease  accounts for approximately 47% to 65% of lower limb arterial diseases*, resulting in significant clinical manifestations such as intermittent claudication and chronic limb-threatening ischemia, which critically affect patients' quality of life. Existing evidence suggests that drug-eluting stents offer prolonged drug release and therapeutic effects compared to drug-coated balloons, particularly benefiting patients with complex lesions, including long or calcified segments.

The EF-Lumber™ stent, developed independently by Easy-flow™, is designed to align with the anatomical characteristics of the superficial femoral artery. It features a customized stent structure to enhance mechanical support and deployment precision at the proximal end, while accommodating complex vascular conditions at the distal end. The stent's drug coating combines paclitaxel with highly biocompatible fluoropolymers, optimizing sustained release properties for effective long-term treatment with a reduced drug load. Moreover, the stent employs an advanced spraying technology for gradient drug loading, facilitating targeted delivery and precise therapeutic outcomes. Its innovative four-axis delivery system further enhances stability and support in navigating complex, tortuous arteries.

Easy-flow™ has established a comprehensive product portfolio in the domain of lower limb artery stenosis intervention, which includes the EF-Rhine™ constrained dilation balloon catheter, which is already available and used clinically in China, as well as the EF-Yangtze™ below-the-knee rapamycin-coated balloon catheter, which has completed patient enrollment in pre-market clinical trial. The commencement of the EF-Lumber™ clinical trial underscores Easy-flow™'s commitment to advancing innovation within this therapeutic area.

Given that the domestic market for drug-eluting stents is largely dependent on imports, with limited domestic alternatives, Easy-flow™ aims to leverage the clinical data gathered from the EF-Lumber™ trial to foster innovation and development of domestic peripheral drug-eluting stents, ultimately enhancing treatment options available to patients in China.

* 《Chinese Expert Consensus on the Diagnosis and Treatment of Femoral-popliteal Artery Occlusive Disease》