Recently, Shanghai Easy-Flow Medical Tech Co., Ltd. ("Easy-Flow™") announced that its independently-developed EF-Lumber^®Peripheral Drug-Eluting 

Stent has entered NMPA Special Review Procedures for Innovative Medical Devices. 

Clinical evidence from Chinese populations indicates that femoral-popliteal artery occlusion accounts for approximately 47% to 65% of lower extremity 

artery diseases* and can lead to symptoms such as intermittent claudication, ischemic rest pain, and other clinical issues, posing a significant threat 

to limb viability, quality of life, and patient survival.The EF-Lumber^® DES integrates several key innovation features，including a quad-axial system with 

a braided shaft design that facilitates stable and accurate implantation of the stent, a stent structure design combining open and closed cells ensures 

greater stability and minimizes stent migration after implantation, and a gradient drug coating technology ensuring precise drug delivery to the vessel 

wall while significantly reducing drug concentration in the blood circulation. 

Currently, Easy-Flow™ is conducting a prospective, multicenter, randomized controlled clinical trial to  evaluate the safety and efficacy of EF-Lumber^®

DES in treating femoral-popliteal artery stenosis or occlusion. This study is led by Professor Dai Xiangchen from Tianjin Medical University General 

Hospital and Professor Guo Lianrui from Xuanwu Hospital, Capital Medical University. In the enrolled cases, EF-Lumber^®DES has demonstrated excellent 

performance in stent delivery stability and immediate post-deployment outcomes, earning high praise from clinical experts.

Compared with the widely adopted drug-coated balloon therapy in clinical practice, drug-eluting stents show marked efficacy advantages in treating 

lower-extremity arterial disease: they deliver prolonged drug release, sustained therapeutic action, and require substantially lower drug dosages. Notably, 

for complex lesions such as long-segment or calcified obstructions in the lower extremities, these stents exhibit enhanced durability and superior clinical 

outcomes. At present, China's peripheral drug-eluting stent market remains dominated by imported products, with domestic brands yet to establish a 

strong competitive presence. The EF-Lumber^®DES is poised to fill this market gap by offering clinicians a more cost-effective solution.

The special review and approval for EF-Lumber^®DES by NMPA not only demonstrates Easy-Flow™'s innovative capabilities in the field of peripheral vascular

 intervention but also injects new momentum into the independent innovation of domestic medical devices. Ms. Miao Zhenghua, Chairman and General 

Manager of Easy-Flow™, commented: "Easy-Flow™ is committed to addressing clinical needs and providing patients and doctors with more effective and 

cost-efficient treatment options. We will accelerate the enrollment of our clinical trial for EF-Lumber^®DES, closely track and evaluate its safety and

effectiveness data, and bring this innovative product to market as soon as possible, benefiting a wide range of patients."

*Bao Junmin, Liu Bing, Shen Chenyang, Zou Junjie. Diagnosis and Treatment of Femoral-Popliteal Artery Occlusion: Chinese Expert Consensus. Chinese Circulation Journal, 2022(7):669-676.