NORTION Compound Steep Pulse Therapeutic Apparatus

Technical Principle
Applications
Product Advantages
Product Configuration

Technical Principle

NORTlON Compound Steep Pulse Therapeutic Apparatus employs Irreversible Electroporation (IRE) mechanism, delivering microsecond-level, bipolar positive/negative, high-intensity composite pulses to solid tumors. This induces tumor cell apoptosis through irreversible electroporation while simultaneously activating the body's anti-tumor immune response.

Irreversible Electroporation (IRE) Technology
Irreversible electroporation operates by applying high-voltage electric fields through a pulse generator that delivers microsecond-duration electric pulses. This induces transmembrane potential formation on cell membranes, locally overcoming the dielectric strength of phospholipid bilayers. The process creates hydrophilic nanopores (nanometer-scale pores) within the lipid bilayer, altering membrane permeability. When energy exceeds threshold levels, it causes permanent membrane permeabilization, disrupting intracellular homeostasis and triggering programmed cell apoptosis.
Key Features of Irreversible Electroporation (IRE) Technology
1. Non-Thermal Ablation : Ensures procedural safety with no anatomical restrictions, Eliminates risk of rectal fistula associated with traditional thermal ablation.
2. High Tissue Selectivity : Preserves vascular structures and neural bundles within ablation zones,Maintains sexual function and urinary continence in prostate cancer patients.
3. Ultra-Minimally Invasive : Requires only 1mm-diameter needles (sub-millimeter scale).

Applications

1
Recommended for ablation therapy in adult male patients with low- to intermediate-risk localized prostate cancer meeting all criteria：

· PSA<20 ng/mL
· Clinical stage T1a-T2c
· Gleason Score ≤7 (Grade Group 2 per ISUP 2014)
2
Recommended for relieving lower urinary tract symptoms (LUTS) in male patients with benign prostatic hyperplasia (BPH) meeting all criteria：

· Age ≥50 years
· International Prostate Symptom Score (IPSS) ≥12
· Prostate volume ≥30 cm³

Product Advantages

High-Frequency Irreversible Electroporation (H-FIRE, a new-generation IRE technology)

therapeutic device features four significant advantages.

More Complete Ablation

Well-Demarcated Boundaries

Induces near-total cellular apoptosis (≈100%) within the ablation zone

Urinary Continence

Tissue-Selective Ablation

Clinically Prevents Urethral Trauma and Nerve Injury to Continence-Governed Structures

Sexual Function

Precision Preservation of Sexual Function via Clinically Insignificant Impact on Neurovascular Structures

Ultra-Minimally Invasive

Streamlined Operation

Short Procedure Time

Minimal Bleeding & Complications

CSCO Prostate Cancer Diagnosis and Treatment Guidelines 2024

Anterior
Placement
Intermediate-Risk Localized
Grade Group2(CSCO 2B）
Additional
Option
Low-Risk Localized
Grade Group3(CSCO 3B）
Anterior
Placement
Low-Risk Localized
Grade Group3(CSCO 3B）
Additional
Option
Recurrence After Definitive Radiotherapy
PSADT< 9months
Grade Group3(CSCO 3B）
Additional
Option
Recurrence After Definitive Radiotherapy
PSADT> 9months
Grade Group2(CSCO 3B）

Product Configuration

No.	Component	Specifications
1	Display	Displays User Interface
2	Emergency Stop Switch	Controls High-Voltage Circuits of Composite Steep Pulse Therapeutic Device
3	Computer Power Switch	Controls startup/shutdown
4	Electrode Needles	Deliver therapeutic pulses
5	Medical Keyboard	Software Parameter Configuration & Functional Button Control
6	Handrail	Facilitates Movement of Composite Steep Pulse Therapeutic Device
7	Electrode Port	Connect Electrode Needles to Deliver Therapeutic Pulses
8	Castors	Facilitates Secure Mobility and Positioning of Composite Steep Pulse Therapeutic Device
9	Footswitch	Connects to Footswitch for Pulse Delivery Initiation and Termination