Good News | The 61st Certificate! Gelatin Sponge Particle Embolic Agent Granted Registration Approval

Recently, the gelatin sponge particle embolic agent independently developed by Suzhou Mednuoyi Medical Technology Co., Ltd., a subsidiary of Mednuo Medical Group, has obtained the Class III medical device registration certificate approved by the National Medical Products Administration (NMPA), with the registration certificate number: Guoxiezhuzhun 20263131683.

This marks the 61st registration certificate acquired by Mednuo Group.

·Gelatin Sponge Particle Embolic Agent

The newly approved gelatin sponge particle embolic agent (Registration No.: Guoxiezhuzhun 20263131683) is a white or pale yellow porous sponge-like particle made from bovine-derived gelatin. Featuring non-antigenicity, high structural strength and excellent conformability, it is widely used as a fundamental embolic agent in transarterial chemoembolization (TACE), uterine artery embolization (UAE) and emergency hemostasis.

Mechanism of Action

After being injected into the target blood vessel, the particles first occlude the vascular lumen via mechanical packing. The sponge-like structure promotes the aggregation of red blood cells, platelets and fibrin, activates the thrombosis pathway, and forms temporary vascular occlusion. As the material degrades over time, the occluded vessel can be recanalized. This property makes the product particularly suitable for scenarios where vascular access needs to be preserved and repeated intervention may be required.

The application of sponge embolic agents is recommended in numerous clinical guidelines, covering the following scenarios:

· Embolization of feeding arteries for hypervascular parenchymal organ tumors: TACE for liver cancer, renal cancer, and partial liver metastases

· Gynecological intervention: uterine artery embolization (UAE) for uterine fibroids/adenomyosis

· Arterial hemorrhage: traumatic hemorrhage, postpartum hemorrhage, arterial gastrointestinal bleeding, preoperative portal vein branch embolization, etc.

Product Features

· Biodegradability: The particles are biodegradable and can be completely degraded within 1 to 3 months. As a non-permanent embolic agent, it creates conditions for multiple TACE procedures in subsequent treatment.

· Morphological advantages: The irregular sponge-shaped particles have excellent compressibility and strictly controlled particle size. They can be smoothly delivered through catheters to reach peripheral vessels for dense embolization, while reducing vascular injury during the procedure.

· Pre-filled packaging: Packaged in a 20 mL syringe, the product enables flexible and convenient clinical operation, reduces electrostatic interference during transfer, improves surgical efficiency and shortens preoperative preparation time.

· Complete specifications: Adaptable to various embolization scenarios, with integer-grade particle size specifications, including 100μm small particle size and 250μm special particle size designs to provide more clinical options.

· High-quality raw material: Made of bovine-derived gelatin, the embolic particles have wider regional applicability.

Product Specifications

·Product Packaging Illustration

100 mg of embolic particles are contained in a 20 mL polycarbonate syringe, which is further sealed in a blister box.

This syringe-based packaging eliminates the material transfer steps required for conventional vial packaging, delivering greater operational convenience.

·Product Images

·Catheter Compatibility Chart

·Animal Experiment Verification — Stable Embolization Effect with Vascular Recanalization