Three Certificates Granted | Cryoablation System of Mednovo Medical Group Approved for Market Launch!

Recently, three independently developed products of Hangzhou Korigin Medical Devices Co., Ltd., a subsidiary of Mednovo Medical Group, namely Cryoablation Console (Registration Certificate No.: National Medical Device Registration 20263010555), Mapping Catheter (Registration Certificate No.: National Medical Device Registration 20263070547) and Cardiac Cryoablation Catheter (Registration Certificate No.: National Medical Device Registration 20263010651), have been granted Class III medical device registration certificates approved by the National Medical Products Administration (NMPA). This marks another milestone for Mednovo Medical Group in the field of cardiac electrophysiology!

Up to now, the Group has obtained a total of 53 medical device registration certificates.

1、Cryoablation

Cryoablation uses low-temperature freezing technology to destroy abnormal conduction pathways in the atria, thereby eliminating lesions of atrial fibrillation. Its principle is to form ice crystals in tissue cells, cause cell dehydration and electrolyte disturbance through cryotherapy (usually below -40°C), which leads to cell death and blocks the conduction of abnormal electrical activities.

It is applicable for paroxysmal/persistent atrial fibrillation, atrioventricular nodal reentrant tachycardia and other diseases, and is a very mature, safe and widely used treatment technology in the field of cardiac electrophysiology at present.

2、Cryoablation Console

The newly approved Cryoablation Console (National Medical Device Registration 20263010555) is used together with the Balloon Cryoablation Catheter produced by the Company for the treatment of drug-refractory, recurrent and symptomatic paroxysmal atrial fibrillation in adult patients.

Mapping Catheter (National Medical Device Registration 20263070547) is used together with the Balloon Cryoablation Catheter produced by the Company, connects to the electrophysiology recorder through an extension cable, and is used to record pulmonary vein potential signals during electrophysiological examination of atrial fibrillation.

Cardiac Cryoablation Catheter (National Medical Device Registration 20263010651) is used together with specific models of Cryoablation System produced by the Company for the treatment of drug-refractory, recurrent and symptomatic paroxysmal atrial fibrillation in adult patients.

The cryoablation system also includes the Steerable Sheath (National Medical Device Registration 20253030257), an approved product of the Group, which can deliver the ablation catheter into the left heart through the interatrial septum and assist catheter positioning via the control handle.

3、Product Advantages and Features

Cryoablation Console (National Medical Device Registration 20263010555)

1. 1.Full-stack independent R&D: PID algorithm + high-precision proportional valve for precise regulation of cryogenic flow.

2. 2.Precise temperature control: Real-time monitoring of pressure feedback throughout the process to accurately control tissue contact temperature.

3. 3.Dynamic balance: Stable dynamic balance among flow, pressure and temperature.

4. 4.Safe ablation: PLC full-link control, ultra-high system stability and multiple protections to ensure treatment safety.

5. 5.Human-machine interaction: Touch interface with visualized parameters, simple and efficient operation.

6. 6.Patient-friendly: Ultra-fast cryotherapy, mild and painless treatment to improve patient experience.

Mapping Catheter (National Medical Device Registration 20263070547)

1. 1.Support and positioning: Assist in stable positioning of balloon catheter, enhance operational support and improve surgical efficiency.

2. 2.Potential recording: Accurately record pulmonary vein potential signals with clear and reliable electrophysiological data.

3. 3.Real-time monitoring: Provide real-time PV potential monitoring during cryoablation to ensure ablation effect.

4. 4.Safety and flexibility: Flexible catheter tip to reduce the risk of vascular injury and ensure patient safety.

5. 5.Stable signal: Stable electrode contact, fast signal transmission response and continuous and reliable acquisition.

6. 6.Circular mapping: Distal circular design with 8 evenly distributed electrodes for accurate mapping of electrical conduction signals.

Cardiac Cryoablation Catheter (National Medical Device Registration 20263010651)

1. 1.Eight-hole uniform temperature: Eight-hole air intake design with uniform refrigerant distribution to improve ablation consistency.

2. 2.Dual-layer monitoring: Inner and outer double-layer balloon with real-time interlayer pressure monitoring to reduce leakage risk.

3. 3.Bidirectional deflection: Bidirectional adjustable deflection design to adapt to anatomical structure and accurately occlude pulmonary vein ostium.

4. 4.Tip temperature control: Integrated thermocouple at the tip for real-time synchronous temperature feedback with precise and controllable measurement.

5. 5.Pressure relief protection: Built-in pressure relief valve in the handle for automatic pressure release in case of abnormal pressure to ensure pipeline safety.

6. 6.Visual manipulation: High-brightness development marks and ergonomic handle for clear and controllable balloon positioning.