Recently, gelatin embolization microspheres independently developed by Suzhou Mednovo Yi Medical Technology Co., Ltd., a subsidiary of Mednovo Medical Group, have been granted the Medical Device Registration Certificate of the People's Republic of China by the National Medical Products Administration (NMPA), with registration number: 20263131348. As the first product of its kind in China and the second pre-filled syringe-packaged wet gelatin microspheres in the world, this approval marks a key breakthrough for the group in the field of minimally invasive tumor therapy, filling the domestic category gap in gelatin-based embolization microspheres.

To date, the group has obtained a total of 58 medical device registration certificates.

Gelatin Embolization Microspheres

Gelatin embolization microspheres are degradable vascular embolization devices made from medical-grade gelatin. As a representative consumable for short-acting embolization regimens in interventional embolization therapy, they are specially developed for interventional embolization of solid tumors, providing clinicians with a short-acting embolization solution that supports repeated treatments.

The principle of embolization therapy is straightforward: first, precisely locate the blood vessels supplying the tumor via minimally invasive approaches, then inject the embolization microspheres accurately into the target vessels through a catheter to block and cut off the tumor's nutrient supply. Deprived of nutrients, the tumor gradually shrinks and necrotizes, while surrounding healthy tissues remain unaffected.

Product Advantages

The newly approved gelatin embolization microspheres (NMPA Registration No. 20263131348) are indicated for embolotherapy of primary hepatocellular carcinoma in adults and palliative treatment of renal tumors. They are biodegradable and can be fully degraded within 1 to 3 months, classifying them as non-permanent embolic agents. The product also features the following properties:

High sphericity and uniform particle size The microspheres have a regular spherical shape with a hydrophilic and smooth surface, facilitating smooth delivery through catheters and enabling precise embolization.

Excellent mechanical properties with high elasticity The product can withstand over 80% compression without rupture, allowing easy passage through microcatheters to reach peripheral vessels for dense and conformal embolization.

Outstanding suspension performance The gelatin embolization microspheres exhibit excellent suspendability, ensuring uniform and stable dispersion of microspheres during transarterial chemoembolization (TACE) procedures, enabling smooth and controllable injection. This allows efficient delivery of microspheres to the target site, improving embolization efficacy and significantly reducing surgical risks.

Large syringe packaging The unique 20mL syringe package has sufficient capacity to hold the full volume of microsphere suspension required for a single procedure, realizing "one preparation for the entire surgery". It eliminates the need for aspiration and transfer from vials before surgery, simplifying the operational workflow and reducing the additional risk of contamination caused by repeated operations.

Diverse specifications with favorable catheter compatibility The product is available in multiple specifications with good catheter compatibility to meet various clinical needs, compatible with catheters of inner diameters including 4.0F (0.97mm), 2.7F (0.65mm), 2.4F (0.53mm) and 1.7F (0.43mm), covering models GM-70, GM-100, GM-300, GM-500, GM-700 and GM-900.

Product Specifications

The product comes in six specifications in total. Each unit contains 1 mL of embolization microspheres plus 7 mL of normal saline, filled in a 20mL polycarbonate syringe, which is then sealed in a blister tray for protection.