Shanghai, China – May 7, 2026 – MicroPort® Endovastec™ recently announced that its SunFlow™ Drug-Eluting Peripheral Stent System (“SunFlow™”) has been granted access to the National Medical Products Administration (NMPA) special review procedures for innovative medical devices, known as the Green Channel. This marks the tenth product from MicroPort® Endovastec™ to receive this designation.
Peripheral Artery Disease (PAD) is a common vascular condition characterized by the narrowing or occlusion of arteries outside the heart and brain, most frequently affecting the lower extremities. Patients typically experience symptoms ranging from intermittent claudication and rest pain to severe tissue loss or amputation. For symptomatic patients, percutaneous endovascular interventions - including balloon angioplasty and stent implantation - represent vital revascularization strategies.
SunFlow™ is indicated for the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery. The system incorporates three key design features intended to address the technical demands of peripheral arterial intervention:
1. Dual‑layer targeted sustained‑release drug coating: designed to enable controlled and sustained drug release for long‑term inhibition of intimal hyperplasia, with targeted drug delivery intended to improve long‑term vascular patency.
2. Hybrid closed‑cell and open‑cell stent design: intended to combine radial strength, flexibility, and deployment stability, accommodating complex mechanical loading conditions in peripheral arterial vessels while supporting stent fatigue resistance, and reducing the risk of vessel injury, stent fracture, and restenosis.
3. Dual‑rail enhanced delivery system design: designed to improve traversal of complex tortuous lesions, enabling precise stent positioning and stable deployment.
“MicroPort® Endovastec™ has established a growing peripheral vascular intervention portfolio with nine commercially available products covering PTA balloon catheters, drug-coated balloon catheters, high-pressure balloons, peripheral stents, and detachable coils,” said Zhenyu Yuan, PhD, Advanced Vice President of R&D at MicroPort® Endovastec™. “The SunFlow™ Green Channel designation, alongside that of our Reewarm™ PTX Drug-Coated PTA Balloon Catheter, reflects our continuous focus on clinical innovation in this space, and we are encouraged by the preliminary clinical performance observed to date.”
“Peripheral vascular intervention represents a significant area of unmet clinical needs, and access to locally developed drug-eluting stent options remains limited in China” said Qing Zhu, PhD, President of MicroPort® Endovastec™. “The NMPA Green Channel designation is expected to accelerate the regulatory review process for SunFlow™ and reflects MicroPort® Endovastec™’s ongoing commitment to bringing advanced interventional treatment solutions to patients in China and globally.”
MicroPort® Endovastec™ continues to focus on innovation across aortic, peripheral vascular, and tumor intervention therapies with a commitment to expanding treatment options for physicians and improving access to advanced therapies for patients worldwide.
About MicroPort® Endovastec™
Founded in 2012, MicroPort®Endovastec™ (Shanghai MicroPort Endovascular MedTech Group Co., Ltd.; SSE: 688016), an associated company of MicroPort® (MicroPort Scientific Corporation, HKEX: 00853), is a global medical device company focusing on the research, development, manufacturing, and commercialization of aortic, peripheral vascular and tumor interventional devices.
MicroPort® Endovastec™'s product portfolio includes thoracic and abdominal aortic stent grafts, stent grafts in surgical operation, peripheral vascular stents, drug-coated balloon dilatation catheters, balloon dilatation catheters, vena cava filters, snare retrieval kits, thrombectomy device, and tumor embolization microspheres. The company is committed to advancing emerging technologies in great vessel surgery and peripheral vascular medicine and to providing access to state-of-the-art solutions for patients worldwide.
More information is available at: www.endovastec.com/en
Regulatory disclaimer
The SunFlow™ Drug-Eluting Peripheral Stent System has been granted access to the NMPA special review procedures for innovative medical devices in China. This designation does not constitute marketing approval. Regulatory status varies by country and region. Healthcare professionals should refer to applicable local regulatory requirements and instructions for use.
References
Data on file, MicroPort® Endovastec™. Clinical trial ongoing; results pending.