R-ONE Vascular Intervention Surgical Robot

R-ONE achieved NMPA approval in December 2023 as China’s first commercially available coronary percutaneous coronary intervention (PCI) surgical robot. Developed through a joint venture between MicroPort MedBot and France’s Robocath S.A.S., the system addresses the precision and radiation exposure challenges of conventional catheter-based coronary intervention.

Product Overview

CathBot (Shanghai) Robotics Co., Ltd., the joint venture established by MicroPort MedBot and Robocath, completed multicenter clinical trials leading to NMPA market authorization. R-ONE was previously the first robot system in Europe to obtain CE certification for interventional cardiology applications.

Following Siemens Healthineers’ exit from the coronary intervention robot market, R-ONE became the only commercially available PCI surgical robot in China. This unique market position was demonstrated in December 2024 when R-ONE won procurement tenders at five major Shanghai public hospitals including Fudan University Zhongshan Hospital.

Key Features

R-ONE is a coronary PCI robot by MicroPort MedBot and Robocath, featuring dual-hand biomimetic control and a radiation-shielded console that reduces operator exposure by more than 90%.

• Dual-Hand Biomimetic Control: Globally unique technology replicates human hand movements for catheter manipulation
• 360° Continuous Rotation: Enables 0-360° continuous rotation and translation for navigating tortuous vessels
• Sub-Millimeter Stepping: Precision advancement improves accuracy during stent deployment and device positioning
• One-Click Lock/Unlock: Single-operator instrument exchange improves procedural efficiency
• Radiation Protection Console: Ergonomic design shields operators from fluoroscopy exposure, with large-angle shielding screens reducing operator radiation by more than 90%
• 3-Second Quick Installation: Minimalist design enables system setup and breakdown in seconds, minimizing procedural preparation time

Technical Specifications

R-ONE is a CE-certified (2019) and NMPA-approved (2023) PCI platform, combining master-slave dual-hand control with sub-millimeter stepping and 0-360° continuous rotation.

Clinical Applications

R-ONE assists cardiovascular intervention physicians in performing percutaneous coronary intervention (PCI) procedures, including:

Primary PCI Applications:

• Coronary angioplasty
• Stent implantation
• Complex lesion navigation
• Chronic total occlusion (CTO) crossing

The robot’s precision control is particularly valuable for complex lesions requiring accurate device positioning and for procedures where tortuous vessel anatomy challenges manual catheter navigation. The radiation-shielded console addresses long-term occupational exposure concerns for high-volume interventional cardiologists.

Multicenter Clinical Trial Results

R-ONE underwent multicenter registration trials at four Chinese hospitals: PLA General Hospital (301 Hospital), Shanxi Cardiovascular Hospital, Meizhou People’s Hospital, and Xinjiang Uygur Autonomous Region People’s Hospital. The trials enrolled 145-149 patients and demonstrated 100% procedural success rate and 100% technical success rate, with the shortest recorded procedure time of 11 minutes. Multiple centers performed consecutive triple-procedure surgical days.

The trials covered a wide spectrum of lesion complexity, including:

• Dual-branch lesion interventions
• Large-angle twisted vessels with poor coaxiality
• Diffuse long lesions
• Calcified lesions
• Ostial anomaly cases
• Sub-total occlusion procedures

5G Remote Surgery Capability

In July 2023, R-ONE demonstrated 5G-enabled telesurgery when Professor Yundai Chen at PLA General Hospital remotely operated the system to perform a PCI procedure on a patient at Xinjiang Uygur Autonomous Region People’s Hospital — a distance of 2,800 kilometers. This represented China’s first ultra-long-distance robotic coronary intervention and validated the platform’s potential for extending specialist capabilities to underserved regions.

The 5G implementation addresses a fundamental challenge in Chinese healthcare: the geographic concentration of interventional cardiology expertise in major urban centers. Remote-capable robotics could enable experienced operators to guide or perform complex procedures at distant facilities, potentially improving outcomes for patients who cannot access tertiary cardiac centers.

Regulatory Status

R-ONE was the first robot system to achieve CE certification for the interventional cardiology application category in Europe.

Commercial Progress

As of end 2024, R-ONE achieved 18 global orders including 8 domestic installations. The December 2024 tender wins at five Shanghai tertiary hospitals—including Fudan University Zhongshan Hospital—represented a significant commercial breakthrough, validating market acceptance at leading cardiovascular centers.

The system’s open architecture design ensures compatibility with mainstream interventional devices and catheterization laboratory equipment, facilitating integration into existing hospital infrastructure without requiring full equipment replacement.

Joint Venture Structure

R-ONE exemplifies MicroPort MedBot’s strategy of international collaboration for specialized surgical robot development. CathBot Shanghai combines:

• Robocath S.A.S. (France): Core robotic technology and European regulatory experience
• MicroPort MedBot (China): Manufacturing capability, China market access, and clinical trial infrastructure

This model enabled R-ONE to build on established European technology while achieving China-specific regulatory approval and commercial deployment.

Frequently Asked Questions

What is PCI surgery and why use a robot?

Percutaneous coronary intervention (PCI) involves catheter-based treatment of blocked coronary arteries, typically including angioplasty and stent placement. Robotic assistance improves precision during device positioning and reduces radiation exposure to physicians who perform many procedures.

Is R-ONE the only coronary intervention robot in China?

Yes, following Siemens Healthineers’ market exit, R-ONE became the only commercially available PCI surgical robot in the Chinese market as of late 2024.

How does R-ONE protect physicians from radiation?

The radiation-shielded control console allows physicians to operate from a protected position rather than standing at the patient table during fluoroscopy. Large-angle shielding screens reduce operator radiation exposure by more than 90%, significantly extending the sustainable career duration for high-volume interventionalists.

What is the learning curve for R-ONE?

According to CathBot, the system features simplified operation protocols with a short learning curve. Physicians can achieve proficiency after basic training, as the master-slave control interface translates familiar manual manipulation gestures into robotic commands.

How does R-ONE handle emergency conversion to manual operation?

The system includes rapid disengagement capability. One-key release allows immediate transition to manual operation if needed during a procedure, with 3-second disconnection time.

Can R-ONE be used with any catheterization laboratory?

R-ONE’s architecture maintains compatibility with mainstream interventional devices and catheterization laboratory equipment currently in use. The system integrates with existing infrastructure rather than requiring dedicated facility modifications.

What are the consumable costs for R-ONE procedures?

CathBot has emphasized that the minimalist design reduces consumable costs compared to some competing platforms. Specific pricing information is not publicly disclosed.