TITIAN Cardiac Electrophysiology Intervention Control System

TITIAN (提香) became China’s first domestically developed cardiac electrophysiology intervention control system to receive NMPA approval in October 2025. Developed by MEIO CardiNav Medical, this dual-arm robotic platform enables physicians to perform catheter ablation procedures with sub-millimeter positioning accuracy while operating from outside the X-ray radiation zone.

Product Overview

TITIAN addresses two persistent challenges in cardiac electrophysiology procedures: the long learning curve for complex ablation techniques and the occupational radiation exposure that accumulates over a physician’s career. The system provides quantified catheter control that standardizes manipulation techniques while allowing experienced operators to maintain procedural efficiency.

The platform entered the NMPA Innovation Medical Device Special Review Program (green channel) in March 2023, becoming the first cardiac intervention control system to qualify for this accelerated pathway. This designation reflected regulatory recognition that the dual-arm architecture and integrated sheath-catheter control represented genuine innovation rather than incremental improvement.

Key Features

Dual-Arm Simultaneous Control: Independent servo systems manipulate the introducer sheath and ablation catheter concurrently, replicating two-handed operator technique. This addresses a fundamental limitation in conventional robotics that control only the catheter.

Real-Time Sheath Visualization: The system displays fixed-curve sheath position graphically during three-dimensional mapping, solving a clinical blind spot where standard mapping systems cannot track sheath orientation.

Sub-Millimeter Positioning Accuracy: Quantified control enables precise catheter-tissue contact positioning with documented accuracy below 1mm, supporting consistent ablation lesion formation.

Remote Operation Capability: Physicians control procedures from a console outside the radiation zone, eliminating cumulative X-ray exposure without compromising procedural precision.

Multi-Manufacturer Compatibility: TITIAN accommodates mainstream pressure-sensing ablation catheters and adjustable-curve introducer sheaths, preserving physicians’ ability to use familiar consumables.

Technical Specifications

Designed for cardiac electrophysiology, TITIAN controls both the introducer sheath and ablation catheter simultaneously with sub-millimeter accuracy, letting operators work from outside the X-ray zone.

Clinical Applications

TITIAN targets cardiac arrhythmia ablation procedures requiring three-dimensional electroanatomical mapping. Primary indications include:

Atrial Fibrillation: Pulmonary vein isolation procedures for paroxysmal and persistent AF. Registration trial data demonstrated 5.2% lower 12-month recurrence rates compared to manual ablation, attributed to improved catheter-tissue contact stability during energy delivery.

Atrial Flutter: Cavotricuspid isthmus ablation for typical flutter with enhanced positioning reproducibility.

Complex Arrhythmias: Substrate modification procedures in patients with structural heart disease where precise lesion placement is critical.

Clinical trials at Sir Run Run Shaw Hospital (Zhejiang University) demonstrated that the robotic approach significantly reduced catheter-tissue contact pressure variability during cardiac rhythm, achieving stability improvements of approximately one order of magnitude compared to manual manipulation.

Regulatory Status

TITIAN completed multicenter registration clinical trials in 2024 and received NMPA Class III medical device approval on October 31, 2025. The device is the first cardiac electrophysiology surgical robot to complete clinical trials and achieve market authorization in China.

Development Timeline

• 2021: Animal experiment completion
• 2023 January: First human clinical trial at Sir Run Run Shaw Hospital
• 2023 March: Entered NMPA innovation green channel
• 2024: Multicenter registration trial completion
• 2025 October: NMPA approval received

Frequently Asked Questions

How does TITIAN compare to manual catheter ablation?

Clinical trial data showed 5.2% lower atrial fibrillation recurrence at 12-month follow-up with TITIAN-assisted procedures. The primary mechanism appears to be improved catheter-tissue contact stability during ablation, with contact pressure variability reduced by approximately one order of magnitude.

What training is required for TITIAN?

The system was designed to shorten the learning curve for complex electrophysiology procedures. The dual-arm control interface replicates familiar two-handed catheter manipulation techniques, and MEIO CardiNav reports that operators can rapidly adapt to robotic-assisted procedures.

Does TITIAN work with existing EP lab equipment?

TITIAN integrates with major three-dimensional electroanatomical mapping systems and accepts mainstream ablation catheters and introducer sheaths from multiple manufacturers, allowing hospitals to use existing inventory and workflows.