SafeCut Coronary Cutting Balloon Dilatation Catheter
SafeCut™ is a coronary cutting balloon dilatation catheter developed by Shunmei for lesion preparation in coronary intervention. As a specialized cutting balloon catheter, SafeCut combines balloon dilation with blade-based scoring to support controlled vessel preparation before further interventional treatment.
For healthcare partners looking for a coronary cutting balloon, balloon dilatation catheter, or catheter with balloon for coronary applications, Shunmei provides SafeCut with a product design focused on precise cutting, smooth delivery, and controlled dilation in selected coronary lesions.
Key Features of SafeCut Cutting Balloon Catheter
SafeCut is designed with structural and material features that support lesion crossing, catheter delivery, and balloon dilation in coronary intervention.
| Feature | Design Focus | User Value |
|---|---|---|
| Dual-layer design | Inner layer supports burst performance; outer layer supports navigation | Helps the balloon pass through narrow and complex vessel pathways |
| Non-compliant balloon | High-pressure resistance up to 20 atm | Supports controlled expansion during lesion preparation |
| High-pushability shaft | Shaft design focused on support and delivery | Helps support catheter advancement through complex lesion areas |
| Low-friction hydrophilic coating | Surface coating designed to reduce friction resistance | Supports smoother catheter delivery and navigation |
| Sharp-edged blade design | Blade structure for directional cutting | Supports controlled lesion scoring before balloon dilation |
| Small profile design | Entry profile of 0.0162 in and tip crossing profile of 0.0220 in | Helps support crossing performance in selected coronary pathways |
Technical Specifications
SafeCut is developed for use with standard coronary intervention workflows and product configurations.
| Technical Item | Specification |
|---|---|
| Product name | SafeCut™ Coronary Cutting Balloon Dilatation Catheter |
| Manufacturer | Shunmei |
| Guide wire compatibility | 0.014 in |
| Effective catheter length | 145 cm |
| Entry profile | 0.0162 in |
| Tip crossing profile | 0.0220 in |
| Balloon design | Non-compliant balloon |
| High-pressure resistance | 20 atm |
Models and Sizes
| Code | Model Number | Balloon Diameter (mm) | Balloon Length (mm) | Catheter Length (cm) | Total Blades | Blade Rows | Crossing Profile (in) |
|---|---|---|---|---|---|---|---|
| 635519 | 2.00×5 | 2 | 5 | 145 | 3 | 3 | 0.0460 |
| 635520 | 2.00×10 | 2 | 10 | 145 | 6 | 3 | 0.0460 |
| 635521 | 2.00×15 | 2 | 15 | 145 | 9 | 3 | 0.0460 |
| 635762 | 2.00×20 | 2 | 20 | 145 | 12 | 3 | 0.0460 |
| 635522 | 2.25×5 | 2.25 | 5 | 145 | 3 | 3 | 0.0460 |
| 635523 | 2.25×10 | 2.25 | 10 | 145 | 6 | 3 | 0.0460 |
| 635524 | 2.25×15 | 2.25 | 15 | 145 | 9 | 3 | 0.0460 |
| 635763 | 2.25×20 | 2.25 | 20 | 145 | 12 | 3 | 0.0460 |
| 635525 | 2.50×5 | 2.5 | 5 | 145 | 3 | 3 | 0.0490 |
| 635526 | 2.50×10 | 2.5 | 10 | 145 | 6 | 3 | 0.0490 |
| 635527 | 2.50×15 | 2.5 | 15 | 145 | 9 | 3 | 0.0490 |
| 635764 | 2.50×20 | 2.5 | 20 | 145 | 12 | 3 | 0.0490 |
| 635528 | 2.75×5 | 2.75 | 5 | 145 | 3 | 3 | 0.0490 |
| 635529 | 2.75×10 | 2.75 | 10 | 145 | 6 | 3 | 0.0490 |
| 635530 | 2.75×15 | 2.75 | 15 | 145 | 9 | 3 | 0.0490 |
| 635765 | 2.75×20 | 2.75 | 20 | 145 | 12 | 3 | 0.0490 |
| 635531 | 3.00×5 | 3 | 5 | 145 | 3 | 3 | 0.0520 |
| 635532 | 3.00×10 | 3 | 10 | 145 | 6 | 3 | 0.0520 |
| 635533 | 3.00×15 | 3 | 15 | 145 | 9 | 3 | 0.0520 |
| 635766 | 3.00×20 | 3 | 20 | 145 | 12 | 3 | 0.0520 |
| 635534 | 3.25×5 | 3.25 | 5 | 145 | 3 | 3 | 0.0520 |
| 635535 | 3.25×10 | 3.25 | 10 | 145 | 6 | 3 | 0.0520 |
| 635536 | 3.25×15 | 3.25 | 15 | 145 | 9 | 3 | 0.0520 |
| 635767 | 3.25×20 | 3.25 | 20 | 145 | 12 | 3 | 0.0520 |
| 635537 | 3.50×5 | 3.5 | 5 | 145 | 4 | 4 | 0.0570 |
| 635538 | 3.50×10 | 3.5 | 10 | 145 | 8 | 4 | 0.0570 |
| 635539 | 3.50×15 | 3.5 | 15 | 145 | 12 | 4 | 0.0570 |
| 635768 | 3.50×20 | 3.5 | 20 | 145 | 16 | 4 | 0.0570 |
| 635549 | 3.75×5 | 3.75 | 5 | 145 | 4 | 4 | 0.0570 |
| 635550 | 3.75×10 | 3.75 | 10 | 145 | 8 | 4 | 0.0570 |
| 635551 | 3.75×15 | 3.75 | 15 | 145 | 12 | 4 | 0.0570 |
| 635769 | 3.75×20 | 3.75 | 20 | 145 | 16 | 4 | 0.0570 |
| 635552 | 4.00×5 | 4 | 5 | 145 | 4 | 4 | 0.0580 |
| 635553 | 4.00×10 | 4 | 10 | 145 | 8 | 4 | 0.0580 |
| 635554 | 4.00×15 | 4 | 15 | 145 | 12 | 4 | 0.0580 |
| 635770 | 4.00×20 | 4 | 20 | 145 | 16 | 4 | 0.0580 |
For detailed model availability, balloon sizes, and product documentation, please contact Shunmei.
Clinical Evaluation
According to the clinical evaluation summary shown below, SafeCut reported a device-use success rate of 97.62% in the experimental group, compared with 96.39% in the control group. The safety summary also reported no statistical difference in safety indicators between the two groups and no device defects during the study.
| Primary Efficacy Endpoint | Experimental Group | Control Group |
|---|---|---|
| Success rate of device | 97.62% | 96.39% |
| 95% CI | [-3.94%, 6.41%] | |
| Non-inferiority | Established (CI lower limit > -10%) | |
| Safety Results | Experimental Group | Control Group |
|---|---|---|
| AE incidence rate | 32.14% | 34.52% |
| Equipment-related AE | 1 case | — |
| There was no statistical difference in safety indicators between the two groups, and no device defects occurred. | ||
Clinical data, applicable claims, and regulatory status may vary by market. Please contact Shunmei for approved product documentation and regulatory information.
Shunmei Support for SafeCut
As a coronary balloon supplier, Shunmei supports SafeCut with experience in interventional catheter and balloon product development. Shunmei provides product specifications, technical documentation, clinical summary information, and cooperation support to help healthcare partners evaluate SafeCut for different market requirements.
