ETcath Vascular Intervention Robot
Developed by Beijing-based WeMed Medical, ETcath became the world’s first interventional surgery robot to integrate “Eye-Hand-Brain” functionality when it received NMPA approval in March 2025. The system enables physicians to perform percutaneous coronary intervention (PCI) procedures remotely, manipulating catheters, guidewires, balloons, and stents with submillimeter precision while remaining outside the radiation zone.
Product Overview
ETcath addresses two persistent challenges in interventional cardiology: radiation exposure to physicians and the physical demands of complex catheter manipulation. By allowing operators to control procedures from a shielded console, the system significantly reduces occupational radiation dose while eliminating the fatigue-induced variability that can occur during lengthy interventions.
The robot supports the complete PCI workflow including guidewire navigation, balloon catheter delivery, stent deployment, and IVUS catheter manipulation. Unlike some competing systems that handle only guidewire advancement, ETcath accommodates multiple catheter types within a single procedure.
Key Features
ETcath’s 0.01 N force sensing and sub-0.05 mm motion accuracy give interventionalists tactile feedback and guidance that manual catheter manipulation cannot match.
- Submillimeter Motion Control: Robotic arm positioning accuracy below 0.05mm enables precise navigation through tortuous coronary anatomy
- Ultra-Sensitive Force Feedback: Force sensing capability as low as 0.01 Newtons allows operators to detect subtle resistance during catheter advancement
- High-Resolution Imaging Integration: Integrated DSA imaging achieves 0.1mm lesion identification accuracy, five times more precise than human visual perception
- Multi-Catheter Compatibility: Supports guidewires, balloon catheters, stent delivery systems, and IVUS catheters within the same procedure
- Rapid Sterile Setup: Disposable sterile cassette with magnetic quick-release enables 3-second instrument mounting
- Remote Operation Console: Physician operates from radiation-shielded position with full procedural control
Technical Specifications
With motion accuracy below 0.05 mm, force sensing down to 0.01 N, and imaging resolution at 0.1 mm, ETcath supports guidewires, balloons, stents, and IVUS catheters in the same PCI session.
| Parameter | Specification |
|---|---|
| Motion Accuracy | < 0.05mm |
| Force Sensing | 0.01 N minimum |
| Imaging Resolution | 0.1mm level |
| Sterile Cassette Change | 3 seconds |
| Supported Devices | Guidewires, Balloons, Stents, IVUS |
| Clinical Applications | PCI, Coronary Intervention |
Clinical Applications
ETcath is indicated for percutaneous coronary intervention procedures including:
- Diagnostic coronary angiography assistance
- Guidewire navigation across coronary lesions
- Balloon angioplasty with precise positioning
- Coronary stent deployment
- Intravascular ultrasound (IVUS) catheter manipulation
The system completed China’s first prospective randomized controlled clinical trial (RCT) for an interventional surgery robot, conducted across five top-tier Grade A tertiary hospitals including Beijing Anzhen Hospital. This trial design provides more rigorous clinical evidence compared to single-arm studies commonly used for device approval.
Regulatory Status
| Region | Status | Date |
|---|---|---|
| China (NMPA) | Approved | March 2025 |
| Europe (CE) | Not Applied | - |
| USA (FDA) | Not Applied | - |
The ETcath received NMPA approval through the Green Path Channel on March 21, 2025, becoming the first domestically-developed coronary interventional robot approved for therapeutic clinical use in China. In October 2025, ETcath200 was selected for Beijing’s First Major Technical Equipment Catalog.
Clinical Validation
The landmark clinical case occurred on October 8, 2021, when Professor Zhou Yujie’s team at Beijing Anzhen Hospital performed China’s first PCI surgery using a domestically-developed vascular intervention robot. The procedure demonstrated the system’s capability to execute the complete intervention workflow:
- Guidewire manipulation through coronary lesion
- Balloon catheter delivery and dilation
- Coronary stent implantation
- IVUS catheter positioning for post-procedure assessment
All manipulations were completed by the ETcath system under physician remote control, validating the transition from manual to intelligent-assisted interventional procedures.
Frequently Asked Questions
What procedures can ETcath perform?
ETcath is designed for percutaneous coronary intervention (PCI) procedures. It supports the full intervention workflow including guidewire navigation, balloon catheter delivery, stent deployment, and IVUS catheter manipulation. The system handles multiple device types within a single procedure.
How does ETcath reduce radiation exposure?
The physician operates ETcath from a shielded console positioned away from the X-ray source. This remote operation eliminates the need for the interventionalist to stand beside the patient during fluoroscopy, significantly reducing cumulative radiation dose over a career of performing interventions.
What is the precision of ETcath’s robotic control?
ETcath achieves motion control accuracy below 0.05mm with force sensing capability as low as 0.01 Newtons. The integrated imaging system provides 0.1mm-level lesion identification, approximately five times more precise than human visual perception.
Has ETcath completed clinical trials?
Yes. ETcath is the first domestic interventional surgery robot to complete a prospective randomized controlled clinical trial (RCT). The multi-center trial was conducted at five top-tier Grade A tertiary hospitals in China, providing rigorous clinical evidence supporting its safety and efficacy.
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Sources
Publicly available references used for the data on this page. See data methodology for verification standards.
