52nd Certificate Granted! Polyvinyl Alcohol Embolization Microspheres Approved

Recently, Polyvinyl Alcohol Embolization Microspheres, independently developed by Suzhou Mednova Yi Medical Technology Co., Ltd., a subsidiary of Mednova Medical Group, has obtained the Medical Device Registration Certificate of the People's Republic of China, with registration certificate No.: National Medical Device Registration 20263130595. This is the 52nd registration certificate obtained by Mednova Medical Group!

1、Tumor Embolization Therapy: The Cutting-edge Technology to "Starve" Cancer Cells

Tumor cells absorb massive nutrients through blood vessels and proliferate rapidly. Embolization therapy blocks the nutrient supply pathway of tumor cells to "starve" the tumor.

The mechanism of embolization therapy is straightforward: Precisely locate the tumor-feeding blood vessels via minimally invasive approaches. Inject embolization microspheres into the target vessels through a catheter to occlude and cut off the tumor’s nutrient supply.The tumor gradually atrophies and necroses due to nutrient deprivation, while surrounding healthy tissues remain unharmed.

2、Product Introduction

The newly approved Polyvinyl Alcohol Embolization Microspheres (National Medical Device Registration 20263130595) are vascular embolization devices featuring a smooth surface, excellent elasticity, diverse specifications, and high safety profile.

They are available in four models: Colorless Type / Colorless Type II and Yellow Type / Yellow Type II.

Colorless Type / Colorless Type II: Translucent to off-white, uniform spherical microspheres.

Yellow Type / Yellow Type II: Light yellow to yellow, uniform spherical microspheres capable of loading Positively charged chemotherapeutic agents.

3、 Indications

As a key material in interventional therapy, Polyvinyl Alcohol Embolization Microspheres (National Medical Device Registration 20263130595) are mainly indicated for embolization treatment of hypervascular malignant tumors in parenchymal organs. Their core clinical value is reflected in two mainstream procedures:

Transcatheter Arterial Chemoembolization (TACE)

In conventional transcatheter arterial chemoembolization (cTACE), the microspheres serve as solid embolization agents used in combination with lipiodol and chemotherapeutic drugs. Delivered via catheter into tumor-feeding arteries, they physically block tumor blood supply, inducing ischemic and hypoxic necrosis to "starve" the tumor.

Drug-eluting Bead Transcatheter Arterial Chemoembolization (DEB-TACE)

A major advancement of TACE, the microspheres act as drug carriers to pre-load chemotherapeutics (e.g., doxorubicin, epirubicin). When injected into tumor vessels, they achieve vascular occlusion and sustainably release high-concentration chemotherapy locally. This dual "embolization + chemotherapy" action enhances tumor cell killing while reducing systemic side effects.

Beyond primary liver cancer treatment, the microspheres are also applicable to:

Uterine Artery Embolization (UAE): Minimally invasive therapy for uterine fibroids, postpartum hemorrhage by blocking uterine blood flow.

Bronchial Artery Embolization (BAE): Treat hemoptysis from bronchial artery injury, or occlude blood supply for thoracic tumors/chest wall sinus bleeding.

Gastrointestinal Embolization: Including AEGCV, PSE, BRTO, etc., for gastrointestinal bleeding or vascular lesions.

Prostatic Artery Embolization (PAE): Shrink hyperplastic prostate tissue via arterial occlusion.

Genicular Artery Embolization (GAE): Alleviate severe knee pain, vascular malformations or tumors by reducing abnormal knee blood flow.

4、Product Advantages

The Polyvinyl Alcohol Embolization Microspheres (National Medical Device Registration 20263130595) offer the following benefits：

1、Superior embolization: Excellent deliverability, reliable immediate/short-term occlusion; animal studies confirm better long-term efficacy than comparable products.

2、Hydrophilic & non-clogging: Smooth surface and uniform shape enable smooth catheter passage without blockage.

3、Pre-filled syringe packaging: Yellow Type/Yellow Type II are pre-loaded in 20mL syringes, simplifying steps, lowering contamination risk, and improving surgical efficiency.

4、Stable in iodine contrast: Maintains particle size and elasticity; withstands 50% compression without rupture in contrast media.

5、Minimal size change after drug loading: Low shrinkage when loaded with doxorubicin-class drugs or irinotecan (Yellow Type/Yellow Type II).

6、Broad & fast drug loading: Compatible with doxorubicin, epirubicin, pirarubicin, irinotecan, etc.; drug loading reaches >90% within 10 minutes.

5、Product Specifications & Models

Diverse models are available to fully meet clinical requirements.

六、Industry Prospect

According to the Global and China Polyvinyl Alcohol Embolization Microspheres Industry Research and 15th Five-Year Plan Analysis Report (2026–2030) by Xinsijie Industrial Research Center, the growing tumor patient population drives strong demand for tumor interventional therapy, fueling continuous market expansion. Global market size: ~5.5 billion RMB in 2024.Projected size: 8.5 billion RMB by 2030