Shanghai Easy-Flow Medical Tech Co., Ltd. ("Easy-Flow™") has officially announced that its independently developed EF-Don™Drug Coated High Pressure Balloon Dilatation Catheter has been approved for market release by the National Medical Products Administration of China (NMPA).It is indicated for the treatment of stenoses in arteriovenous fistula in patients with end-stage renal disease (ESRD) who are undergoing or will undergo hemodialysis.

Vascular access is often referred to as the patient's "lifeline." However, managing stenotic lesions remains a significant clinical challenge. These lesions are typically characterized by high resistance, making them difficult to dilate effectively with conventional balloons, which often require higher inflation pressures ^[1]. Studies have shown a significant negative correlation between the number of repeat interventions following percutaneous transluminal angioplasty (PTA) and long-term patency of the dialysis access ^[2]. The advent of drug-coated balloons (DCBs) offers a promising solution to this challenge. By locally delivering anti-proliferative drugs, DCBs effectively suppress excessive neointimal hyperplasia, significantly prolonging access patency and reducing the frequency of re-interventions ^[3].

The EF-Don^® combines the dual benefits of high-pressure dilation and pharmacological therapy. It not only enables effective dilation of resistant stenoses under high pressure but also delivers paclitaxel, uniformly coated on the balloon surface, directly to the vessel wall at the treatment site. This synergistic approach—integrating mechanical dilation with pharmacological inhibition—helps reduce the risk of restenosis from both physical and biological perspectives. Using proprietary drug-coating technology, the EF-Don^® ensures uniform particle size and consistent paclitaxel distribution, facilitating rapid drug transfer and sustained retention within the vessel wall. Preclinical animal studies have confirmed that therapeutic concentrations of the drug can be maintained in the vessel wall for over 90 days, offering prolonged protection against restenosis.

The pivotal clinical study for EF-Don^® was led by Professor YaXue Shi from Longhua Hospital, Shanghai University of Traditional Chinese Medicine, and Professor Yu Zhao from The First Affiliated Hospital of Chongqing Medical University. This prospective, multicenter, randomized controlled trial enrolled a total of 218 patients. The primary endpoint—target lesion primary patency (TLPP) at 6 months—met the pre-specified non-inferiority criterion: the EF-Don^® group achieved a TLPP rate of 87.96%, compared to 77.27% in the control group (rate difference and 95% CI: 10.69% [0.74%, 20.64%], P_{non-inferiority}< 0.001). Furthermore, EF-Don^® demonstrated superiority over the control group in key secondary endpoints, including TLPP at 12 months, target lesion restenosis rate, and clinically driven target lesion revascularization (CD-TLR).

With the growing number of ESRD patients in China, the need for long-term maintenance of hemodialysis access is becoming increasingly urgent. EF-Don^® not only provides clinicians with a novel therapeutic option but also has the potential to reduce the treatment burden on patients, offering significant clinical and societal benefits.

Ms. Zhenghua Miao , Chairman and General Manager of Easy-Flow™, commented: "EF-Don^® is a drug-coated balloon specifically designed for hemodialysis access stenosis. We are encouraged by its performance in clinical trials. Easy-Flow™ will continue conducting long-term follow-up studies and actively work to improve long-term patency rates and the quality of life for hemodialysis patients. The launch of EF-Don^® further enhances Easy-Flow™'s portfolio in peripheral vascular intervention. We remain committed to innovation and R&D, striving to deliver high-quality, diversified medical solutions to meet evolving clinical needs."

[1] Trerotola SO, Kwak A, Clark TW, et al. J Vasc Interv Radiol. 2005;16(12):1613-1618.
[2] Fan S S, Chen C W, Lu K C, et al. The Journal of Vascular Access, 2017, 18(3): 200–206.
[3] Trerotola S O, Saad T F, Roy-Chaudhury P, et al. Journal of Vascular and Interventional Radiology, 2020, 31(1): 1–14.e5.