Recently, Shanghai Easy-Flow Medical Tech Co., Ltd. ("Easy-Flow™") officially announced the successful completion of patient enrollment in the pre-market clinical trial for its self-developed EF-Lumber^® Peripheral Drug-Eluting Stent. The final patient was enrolled by Professor WenDao Liu and his team from Guangdong Provincial Hospital of Chinese Medicine.

This pivotal clinical study is a prospective, multicenter, randomized controlled trial co-led by Professor Xiangchen Dai from Tianjin Medical University General Hospital and Professor Lianrui Guo from Xuanwu Hospital, Capital Medical University. The trial aims to evaluate the safety and efficacy of EF-Lumber^® in treating stenotic or occlusive lesions in the femoropopliteal artery.

As the population ages, the incidence of peripheral vascular disease continues to rise. Patients with femoropopliteal arterial disease often present initially with intermittent claudication, which can progress to chronic limb-threatening ischemia (CLTI). If left untreated, CLTI may lead to severe complications such as tissue ulcers, gangrene, and even amputation, significantly impairing the patient's quality of life. Drug-eluting stents (DES) offer a crucial treatment option for these lesions. By combining mechanical support with sustained local drug release, DES help maintain long-term luminal patency, offering particular advantages in complex cases, such as long-segment and calcified lesions. However, the femoropopliteal artery is subject to prolonged mechanical stresses—such as stretching, compression, and torsion—requiring stents with high fatigue resistance. Additionally, long-segment lesions are common in clinical practice, which further complicates the precise deployment of longer stents.

EF-Lumber^® has been specifically designed to accommodate the anatomical characteristics and biomechanical environment of the femoropopliteal artery. It features a hybrid closed-cell/open-cell design: the closed-cell proximal segment enhances radial strength and lesion coverage, ensuring precise positioning and stable anchoring after implantation, while the open-cell distal segment improves flexibility and conformability, allowing better adaptation to the tortuous anatomy of the femoropopliteal artery.The stent is coated with paclitaxel combined with a highly biocompatible fluoropolymer. Using gradient spray coating technology, it enables targeted, sustained drug release, maintaining effective local drug concentrations over time with a relatively low total drug dose. This approach minimizes systemic toxicity risks while balancing therapeutic efficacy and safety. Additionally, the device features an innovative four-axis delivery system that enhances pushability, trackability, and overall procedural control, allowing for more efficient navigation and deployment in challenging, calcified, or tortuous lesions.

"The successful completion of EF-Lumber^®'s clinical enrollment marks a significant milestone in Easy-Flow™'s commitment to advancing peripheral vascular interventions," said Ms. Zhenghua Miao, Chairman and General Manager of Easy-Flow™. "From product design to clinical investigation, we have stayed focused on addressing real-world clinical challenges. We sincerely thank all the investigators for their dedication and trust. Moving forward, we will closely monitor follow-up data and work diligently to bring this innovative solution to market as soon as possible."