Certificate No. 43! Mednovo Group's Self-Developed Disposable Microwave Ablation Catheter Receives Market Authorization

2025-11-10 19:32

Recently, the self-developed Disposable Microwave Ablation Catheter (SG), independently developed by Beijing Sanhe Dingye Technology Co., Ltd., a controlled subsidiary of Mednovo Group, has successfully obtained approval for market launch from the National Medical Products Administration (NMPA) (Registration No.: 国械注准20253012201). This marks the 43rd Medical Device Registration Certificate obtained by Mednovo Group. It represents an iterative update to the company's first-generation self-developed product, aiming to advance the product to a higher level through technological innovation and to provide a more convenient and safer treatment option for lower extremity varicose veins.


Disposable Microwave Ablation Catheter (NMPA Registration No.: 20253012201)

Lower extremity varicose veins, a common vascular disease, impact the daily life quality of countless patients. Traditional treatments like stripping surgery, while potentially curative, involve significant trauma and a long recovery period, imposing substantial psychological and economic burdens on patients. The emergence of thermal ablation techniques, such as microwave ablation, laser ablation, and radiofrequency ablation, have all demonstrated certain therapeutic effects in clinical practice.


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Mednovo Group's first-generation self-developed Disposable Microwave Ablation Catheter (NMPA Registration No.: 20233011739) had a diameter of 2.7mm. Clinical trials verified that the product provides excellent and definitive therapeutic outcomes, receiving unanimous recognition from clinicians.


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To achieve even smaller surgical trauma, a technological upgrade was undertaken. The newly certified Disposable Microwave Ablation Catheter (NMPA Registration No.: 20253012201) is used in conjunction with the self-developed Microwave Ablation Device (NMPA Registration No.: 20233011741) for the treatment of great saphenous vein varicose veins (limited to superficial veins).:


Product Advantages:

Ultra-Slim Design: Diameter of only 2.0mm (6F), reducing surgical trauma and enhancing patient comfort.

Multiple Options: Three length specifications to meet the treatment needs of different areas.

Stable & Compatible: Specifically designed for the UM200 Microwave Ablation Device, ensuring stable and controllable energy output for more uniform heating.

Shaft Cooling: Helps prevent thermal damage to healthy patient tissue and provides comfortable, convenient handling for the operator.

MARK Indicator: Added MARK indicator on the shaft facilitates easier operation during procedures.

Verified by in-vitro/animal trials, the product achieves a 100% short-term closure rate, confirming definitive efficacy.

Ultra-slim 2.0mm (6F) design combined with a visible marker technology; operational performance score: 4.9/5.0.

No adverse events such as thrombosis or perforation; hematological indicators showed no abnormalities pre- and post-operation, demonstrating safety and reliability.