Good News | The 62nd Registration Certificate! Polyvinyl Alcohol Embolic Particles Officially Approved

Recently,Suzhou Medinoi Medical Technology Co., Ltd., a subsidiary of Medino Medical Group, has obtained the Class III medical device registration certificate issued by the National Medical Products Administration (NMPA) for its self-developed Polyvinyl Alcohol Particle Embolic Agent, with registration certificate No. 20263132062. This marks the Group’s 62nd registration certificate.

1.Polyvinyl Alcohol Particle Embolic Agent

The newly approved Polyvinyl Alcohol Particle Embolic Agent (Registration No.: 20263132062) is cross-linked and cured through acetalization reaction of polyvinyl alcohol (PVA) and formaldehyde. It appears white or light yellow with an irregular spongy porous structure. Preloaded in a 20 mL polycarbonate syringe, the product features superior embolization performance and easy injection.

As the first domestically produced polyvinyl alcohol particle embolic agent adopting syringe packaging, the product delivers improved convenience and better compliance during clinical procedures.

2. Mechanism of Action

Polyvinyl alcohol embolic particles are non-biodegradable. After being delivered into the target vessel, they physically accumulate to fill the lumen and anchor within the vessel, achieving immediate blood flow occlusion. The surfaces and interstices of the particles facilitate the accumulation of red blood cells, platelets and fibrin, triggering local coagulation. Subsequently, as permanent foreign bodies, the non-degradable particles continuously stimulate the vascular wall, inducing inflammatory response, intimal hyperplasia and fibrosis, which ultimately leads to organized permanent occlusion of the target vessel.

3. Clinical Efficacy

Polyvinyl alcohol particle embolic agents are referenced in numerous clinical guidelines and clinical trials and deliver favorable embolization outcomes, including the following applications:

Hepatocellular Carcinoma

Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2026)

Uterine Fibroids

Expert Consensus on Uterine Artery Embolization for Uterine Fibroids and Adenomyosis (2018)

Bronchial Artery Embolization (Hemoptysis)

Efficacy Evaluation of Bronchial Artery Embolization with Polyvinyl Alcohol Particles for Acute Hemoptysis (2020 Clinical Study)

Gastrointestinal Bleeding

Comparison of microcoils and polyvinyl alcohol particles in selective microcatheter angioembolization of non variceal acute gastrointestinal hemorrhage（Pak J Med Sci）(2015 Clinical Study)

Prostatic Artery Embolization (PAE)

N-Butyl Cyanoacrylate Glue Versus Nonspherical Polyvinyl Alcohol Particles For Prostatic Arterial Embolization（Urol J）(2023 RCT)

Genicular Artery Embolization (GAE)

Genicular artery embolization for the treatment of knee pain secondary to mild to severe knee osteoarthritis: One year clinical outcomes（Eur J Radiol）(2024 Clinical Study)

4. Product Features and Specifications

The newly approved Polyvinyl Alcohol Particle Embolic Agent (Registration No.: 20263132062) is indicated for embolization therapy of hypervascular solid organ malignant tumors. It features the following advantages:

Preloaded Packaging Supplied in a 20 mL prefilled syringe. No transfer required, zero waste and contamination-free. It eliminates static electricity issues and is ready for direct administration after one-step suspension.

Complete Range of Sizes

Designed with integer-grade particle size specifications and a wider selection of particle diameters, it adapts to diverse embolization scenarios and offers clinicians greater options. It also provides optimized particle size solutions for pulmonary vessels. Seven particle size configurations

Favorable Performance in Iodinated Contrast Media

The particles suspend rapidly and maintain stable suspension for an extended duration. They also exhibit minimal particle size variation in non-ionic iodinated contrast media.

Multi-Color Coding

Different particle size variants are marked with distinct color codes to help clinicians avoid confusion during use.

About us

Founded on January 1, 2011, Medino Medical Group is a large diversified group specializing in the healthcare industry, integrating R&D, manufacturing, sales, investment and financing.

Starting with sales, the Group has built a nationwide sales and service network. Combining independent R&D and technology introduction, it has deployed diversified business lines and initially established an R&D, manufacturing and operation system meeting internationally advanced standards. Adopting an innovative industry cooperation model of “financial investment plus sales partnership”, the Group collaborates with outstanding partners, driving projects through investment and fueling growth via projects.

Going forward, the Group will continue its diversified development in the minimally invasive intervention sector. Guided by its strategy and backed by solid financial strength, it takes sales as the foundation and technological innovation as the breakthrough point. It develops hightech innovative products with independent intellectual property rights, high technical content, reliable quality and affordable pricing for patients. The Group strives unremittingly to become a global integrated hightech medical solution provider in the interventional field!