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Shanghai, China – August 27, 2026–MicroPort® Endovastec™ announced that the Aorfix™ AAA Endovascular Stent Graft with IntelliFlex™ Low Profile Delivery System (“Aorfix™”), developed by its European subsidiary Lombard Medical Ltd. (Lombard Medical), has been granted access to China’s National Medical Products Administration (NMPA) Green Channel, a special review pathway for innovative medical devices. This marks the eleventh product from Endovastec™ to receive this designation.

Abdominal Aortic Aneurysm (AAA) is a localized dilation of the abdominal aorta that can be life-threatening upon rupture, with a mortality rate up to 90%. Endovascular abdominal aortic repair (EVAR) has become the preferred treatment for most patients1, though successful outcomes depend on favorable anatomical characteristics1. For patients with severely angulated proximal aortic necks of up to 90 degrees, there is currently no commercially available endovascular device approved in China.

The Aorfix™ is indicated for the endovascular treatment of infra-renal abdominal aortic, iliac, and abdominal aortoiliac aneurysms with peri-renal neck angles up to and including 90 degrees. The system incorporates a number of innovative design features across both its stent graft and delivery system:

Stent Graft：

1) The Aorfix™ main body incorporates a continuous nitinol ring stent design with an offset wire configuration. This architecture is designed to provide exceptional flexibility and conformability, supporting treatment of patients with highly angulated aortic neck anatomy of up to 90 degrees.

2) Following deployment, the proximal rings adopt Aorfix's characteristic fish-mouth configuration, allowing trans-renal placement with suprarenal active fixation intended to preserve alignment with the renal arteries.

3) The stent architecture is designed to reduce the risk of neck dilatation caused by continuous outward radial force, thereby reducing the risk of stent migration and type I endoleaks.

4) The stent rings at the proximal edge of the main body and at the distal end of the legs are positioned closer together than in the rest of main body and leg. This geometry is intended to increase radial force at the sealing zone. Placement of these rings on the inner surface of the graft enhances apposition to the vessel wall and supports an effective proximal seal, which may help reduce type I endoleaks.

5) A unique interlocking mechanism between the main body and iliac limb components provides a secure modular connection, designed to support the long-term component integrity and help reduce the risk of Type III endoleak.

Delivery System：

1) The IntelliFlex™ delivery system of the main body incorporates a proprietary Y-mechanism that supports accurate positioning of the stent graft, facilitates deployment of the characteristic fish-mouth configuration, and assists expansion of the proximal stent.

2) The IntelliFlex™ delivery system incorporates an integrated leave-behind sheath   which can be used after stent graft deployment for continued vascular access.

The Aorfix™ is one of Lombard Medical's flagship products. Across multiple generations, Aorfix™ has received CE certification and regulatory approvals from the U.S. Food and Drug Administration (FDA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The NMPA Green Channel designation for the latest-generation Aorfix™ is expected to accelerate its regulatory review process in China, where the system is intended to provide a new endovascular treatment option for patients with complex abdominal aortic aneurysms.

"The NMPA Green Channel designation for Aorfix™ marks an important milestone in advancing our global development strategy and strengthening our differentiated portfolio for aortic intervention," said Qing Zhu, PhD, President of Endovastec™. "Since acquiring Lombard Medical in 2024, we have continued to integrate global R&D and commercial capabilities, and this designation reflects our commitment to bringing innovative international technologies to patients worldwide." 

About Endovastec™

Founded in 2012, Endovastec™(Shanghai MicroPort Endovascular MedTech Group Co., Ltd.; SSE: 688016), a member of the MicroPort^® Group (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.

Endovastec™'s product portfolio includes thoracic and abdominal aortic stent grafts, surgical stent grafts, peripheral vascular stents, drug-coated balloon dilatation catheters, plain balloon dilatation catheters, vena cava filters, snare retrieval kits, thrombectomy devices, 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.

For more information, please visit: www.Endovastec.com/en

Regulatory Disclaimer

The Aorfix™ Endograft 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

1.Patient Selection Criteria for Endovascular Aortic Aneurysm Repair: Optimizing Outcomes. Semin Intervent Radiol. 2025 Jan 28;41(6):576–580. doi: 10.1055/s-0044-1800848