Recently, the steep pulsed ablation system independently developed by Jingtu Medical Devices (Jiangsu) Co., Ltd., a subsidiary of Mednovo Medical Group, consisting of the Steep Pulsed Therapy Device (NMPA Registration No. 20263091309) and the Disposable Steep Pulsed Ablation Electrode Needle (NMPA Registration No. 20263091302), has obtained Class III medical device registration certificates approved by the National Medical Products Administration (NMPA). The simultaneous approval of the two products marks a major breakthrough for the group in the field of minimally invasive tumor therapy and further improves its product portfolio. To date, Mednovo Medical Group has 57 approved and marketed products.

Steep Pulsed Ablation – Irreversible Electroporation (IRE)

Steep pulsed ablation, also known as irreversible electroporation (IRE), is an emerging ablation therapy. By applying an external high-voltage pulsed electric field, irreversible "nano-scale" pores are formed on the cell membrane, which disrupts cellular osmotic pressure and induces apoptosis. It features no heat sink effect interference, controllable ablation area, no damage to blood vessels, biliary tract and nerves, and the ability to activate immune responses.

Traditional thermal ablation techniques such as radiofrequency and microwave ablation are affected by heat dissipation from adjacent blood flow (the "heat sink effect"), resulting in insufficient local temperature and incomplete tumor ablation. As a non-thermal ablation mechanism, IRE does not damage blood vessels, bile ducts, nerves and other tissues, and its ablation effect is not affected by local blood flow. It has unique advantages in ablating tumors adjacent to blood vessels, providing a safer minimally invasive solution for various difficult lesions.

At present, multiple domestic and international clinical guidelines and studies have included it as a recommended regimen for liver tumor treatment, and long-term follow-up has confirmed its favorable safety and efficacy.

Steep Pulsed Ablation System

NMPA Registration No. 20263091309, NMPA Registration No. 20263091302

The newly approved steep pulsed ablation system consists of a steep pulsed therapy device and disposable steep pulsed ablation electrode needles, indicated for the ablation of malignant solid liver tumors.

Steep Pulsed Therapy Device (NMPA Registration No. 20263091309)，The device supports output from 2 to 6 ablation electrode needles. It features two output modes: ECG synchronization and fixed frequency, enabling precise control of electric field parameters to ensure stable and controllable tumor ablation. It is also equipped with an auxiliary needle placement planning function.

Disposable Steep Pulsed Ablation Electrode Needle (NMPA Registration No. 20263091302)Available in multiple models with different lengths to meet diverse clinical needs. The needle body is marked with depth indicators to assist in judging the insertion depth of the electrode needle.

Preoperative，Screen cases according to indications and contraindications. Measure tumor size via contrast-enhanced CT/MRI and ultrasound. Determine the number of ablation needles and puncture direction based on tumor size and location.

Intraoperative，Place needles as planned under imaging guidance, measure needle spacing and set ablation parameters, then activate the device to deliver steep pulsed energy.

Postoperative， Immediately verify whether the ablation zone covers the entire tumor.

Product Features

Steep Pulsed Therapy Device

Intelligent overcurrent protection：Built-in intelligent overcurrent protection circuit actively prevents risks, allowing physicians to focus on surgery and improving patient safety.

ECG synchronization + fixed mode：Supports ECG-triggered synchronization and fixed mode settings to meet precise ablation needs under different heart rhythm conditions.

Real-time parameter visualization：Dynamically monitors and clearly displays key ablation parameters throughout the procedure, ensuring precise and controllable treatment.

Compact body with simple touchscreen UI：The compact and lightweight device is easy to move and store, paired with an intuitive UI interface and responsive touchscreen.

Disposable Steep Pulsed Ablation Electrode Needle

· Echogenic groove for clear visualization: Enhances echogenicity in ultrasound imaging for real-time tracking of the needle tip, reducing the risk of damage to adjacent vital structures.

· Tri-bevel sharp tip: The tri-bevel structure significantly reduces puncture resistance, enabling smooth puncture with minimal deflection, and lowering the risk of tissue damage and intraoperative displacement.

· Quick depth recognition for precise needle placement: The needle body is equipped with easy-to-read scale markers for real-time depth judgment, assisting physicians in accurately controlling puncture depth and improving operational safety and consistency.

· Intraoperative identification for safety and efficiency: Equipped with dedicated identification stickers to quickly label multiple needles during surgery, enabling clear differentiation and avoiding confusion to ensure safe and efficient multi-needle ablation.

· Three lengths for flexible adaptation: Available in 15cm, 20cm and 25cm specifications to match lesions at different depths.

· Auto-locking push button for precise control: The push button automatically locks into position after adjustment without extra operation, with clear tactile feedback and reliable locking.