Technical Principle
Ablation Characteristics
1. Non-thermal ablation : Ensures no thermal damage to the urethra/rectum
2. Highly tissue-selective : Only ablates glandular tissue while sparing erectile nerves and blood vessels.
3. Ultra-minimally invasive : Causes minimal trauma, with only a few 1mm puncture sites in the perineal area.
Applications
The product is intended for use in medical institutions to relieve symptoms of urinary obstruction in male patients with benign prostatic hyperplasia (BPH) who meet the following criteria: age ≥50 years, International Prostate Symptom Score (IPSS) ≥12, and prostate volume ≥30 cm³.
Product Advantages
Significantly improves lower urinary tract symptoms
Demonstrated a mean maximum urinary flow rate (Qmax) improvement of 8.41 mL/s, International Prostate Symptom Score (IPSS) reduction of 13.04 points, and 20.76% prostate volume shrinkage.；
Preserves continence and sexual function
The tissue-selective/non-thermal ablation spares continence-related nerves, sexual nerves, and muscle fiber structures, thereby enabling complete preservation of urinary continence and sexual function.
The ablation therapy that does not damage the urethral mucosa
The transperineal approach bypasses the urethra without causing damage, thus preserving urethral mucosal integrity.
Ultra-minimally invasive procedure
Features a streamlined workflow with a short learning curve for clinicians, causes remarkably minimal tissue trauma (only a few 1mm puncture sites in the perineal region), and results in no significant bleeding.
Significantly reduced hospitalization duration
Day surgery procedure with hospitalization limited to ≤24 hours.
Product Configuration
| No. | Component | Component Model Number |
|---|---|---|
| 1 | Rack-Mounted Main Control Unit (with Integrated Display) | IRE-BPH-01-A |
| 2 | Bottom Rack Space for Main Control Unit | IRE-BPH-01-B |
| 3 | Footswitch | HRF-M5Y/A |
| 4 | Inter-cabinet signal cable | PT-CNT-36A |
| 5 | Inter-cabinet power cable | / |
| 6 | AC power cable | / |
