Zhongke Hongtai Multi-Channel Vascular Interventional Robot

Developed by Zhongke Hongtai based on nearly two decades of research at the Chinese Academy of Sciences, this multi-channel pan-vascular interventional surgical robot addresses a fundamental limitation in existing systems: the inability to manipulate multiple guidewires simultaneously for complex bifurcation procedures.

Product Overview

The Zhongke Hongtai vascular interventional robot represents a departure from single-channel designs that dominate the current market. Registered with NMPA as “Coronary Artery Interventional Surgery Control System,” the device enables synchronized control of multiple interventional devices—a capability required for treating bifurcation lesions, which account for 15-20% of coronary interventions and carry higher procedural complexity and complication rates.

The system entered NMPA’s Innovative Medical Device Special Review Pathway (Green Channel) in 2024, with registration projected for 2026. Clinical validation includes seven human research cases and dozens of animal experiments, including demonstration of 5G remote operation over 1,000+ kilometers.

Key Features

Multi-Channel Device Control: Unlike single-guidewire systems, this robot coordinates multiple interventional devices simultaneously. The design supports techniques like Culotte, T-stenting, and crush stenting that require independent manipulation of two guidewires through different branch vessels.

Biomimetic Finger Mechanism: The delivery system mimics human finger movements through a multi-digit design enabling:

• Independent axial advancement/retraction of each device
• Independent rotation around device axis
• Coordinated movements for complex maneuvers
• Compatibility with standard guidewires, balloon catheters, and stent systems

Closed-Loop Force Feedback: Proprietary force sensors detect resistance changes during device advancement and transmit tactile information to the operator console. This addresses a critical gap in interventional robotics where lack of haptic feedback increases perforation risk.

Full-Procedure Coverage: The system supports both diagnostic angiography and therapeutic intervention phases, eliminating the need for manual takeover between procedure stages—a limitation in some competing systems designed only for specific procedural steps.

Multi-Specialty Application: While primarily targeting coronary intervention, the platform architecture supports:

• Peripheral vascular intervention (PVI)
• Neurovascular intervention (NVI)
• Structural heart procedures

Technical Specifications

With multi-channel simultaneous guidewire control and closed-loop force feedback, this vascular robot targets the 15–20% of coronary cases involving bifurcation lesions that single-channel systems cannot treat robotically.

Note: Detailed specifications subject to change pending final regulatory submission.

Clinical Applications

The multi-channel architecture specifically addresses complex coronary anatomies that challenge current robotic systems:

Bifurcation Lesions: Lesions at vessel branch points require simultaneous wire access to main vessel and side branch. The robot enables robotic execution of techniques previously requiring manual dexterity:

• Culotte stenting
• T-stenting and TAP
• Crush techniques
• Kissing balloon inflation

Chronic Total Occlusions: Complex CTOs may benefit from controlled, stable wire manipulation with force feedback to sense vessel wall contact.

Tortuous Anatomy: Consistent robotic delivery through curved vessel segments where manual pushability degrades.

High-Risk Patients: Standardized technique execution may benefit patients where procedural variability increases adverse event risk.

Clinical Evidence

Human Research Cases: Seven patients treated under research protocols demonstrating safety and feasibility of multi-channel robotic coronary intervention.

Animal Studies: Dozens of procedures across porcine models establishing:

• Device delivery success rates
• Procedural time benchmarks
• Safety margins for force feedback calibration

Remote Surgery Validation:

• 2021: Beijing-to-Shanghai 5G remote Culotte stenting (claimed world first for this technique robotically)
• 2023: Live demonstration at Oriental Congress of Cardiology opening ceremony

Regulatory Status

The Innovative Medical Device designation indicates NMPA recognition of technical novelty and potential clinical value, qualifying the product for priority review. However, this does not constitute approval or guarantee registration outcome.

Competitive Positioning

Current NMPA-approved vascular interventional robots in China include:

• R-ONE (Cathbot/MicroPort-Robocath): Single-channel PCI robot, first commercial approval in category
• ETcath (WeMed): Domestically developed single-channel system

Zhongke Hongtai positions its multi-channel capability as addressing the 15-20% of coronary cases involving bifurcations that single-channel systems cannot robotically treat. The company emphasizes force feedback as an additional differentiator, though clinical evidence comparing outcomes to existing systems remains pending.

Frequently Asked Questions

What procedures can this robot perform that others cannot?

The multi-channel design enables robotic execution of bifurcation stenting techniques (Culotte, T-stenting, crush) requiring simultaneous control of two guidewires. Current single-channel commercial robots cannot perform these procedures robotically—physicians must switch to manual technique for the bifurcation portion or perform the entire procedure manually.

When will this robot be available for clinical use in China?

The product entered NMPA’s Innovative Device Green Channel in 2024, which provides expedited but not guaranteed review. The company projects obtaining registration approval in 2026. Until then, the system is only available under research protocols at select institutions.

How does the force feedback system work?

Proprietary sensors measure resistance forces during guidewire and catheter advancement. These measurements are processed and translated into tactile feedback at the operator console, providing the physician with a sense of wire tip resistance similar to manual operation. This aims to reduce perforation risk from advancing against excessive resistance without tactile awareness.

Can this robot perform remote surgeries?

The system has demonstrated 5G-enabled remote operation in research settings, including a Beijing-to-Shanghai procedure covering over 1,000 kilometers. However, regulatory pathways for commercial remote surgery use remain under development, and initial clinical deployment will likely focus on same-room operation with the physician at a shielded console.