Navigation-Guided Microwave Ablation System

TrueHealth’s Navigation-Guided Microwave Ablation System integrates precision puncture navigation with thermal ablation therapy in a unified robotic platform. Approved by NMPA in September 2024, the system received designation as an “International First” product, recognizing it as a globally novel device category combining robotic navigation with ablation treatment capabilities.

Product Overview

Percutaneous thermal ablation has emerged as an important treatment modality for patients with unresectable tumors or those who cannot tolerate surgical intervention. However, conventional ablation procedures face two sequential challenges: first achieving accurate probe placement in the target lesion, then delivering effective thermal energy while protecting surrounding structures.

This system addresses both phases through an integrated platform that combines TrueHealth’s established puncture navigation technology with microwave ablation delivery. The unified approach aims to improve targeting accuracy for ablation procedures while reducing the complexity of using separate navigation and treatment systems.

The product holds particular significance for the Hengqin-Macao Deep Cooperation Zone, as it became the first medical device to complete the entire development lifecycle—from project initiation through regulatory approval—within the zone’s boundaries.

Key Features

Integrated Navigation and Ablation: Unlike systems that require separate navigation equipment and ablation generators, this platform combines both functions. Surgical planning, probe positioning, and thermal delivery are managed through a unified control interface.

Precision Probe Placement: The system applies TrueHealth’s optical navigation and respiratory tracking technology to ablation probe positioning, enabling accurate targeting of lesions that move with respiration.

Treatment Planning Support: Image-based planning tools assist clinicians in designing ablation zones that adequately cover target lesions while maintaining safe margins from critical structures.

Real-Time Monitoring: The system provides feedback during the ablation process to help clinicians assess treatment progress and coverage.

Technical Specifications

Approved by NMPA in September 2024 with International First designation, TrueHealth’s system unifies optical navigation with microwave ablation in a single robotic platform.

Clinical Applications

Primary Indications: The system supports microwave ablation treatment of solid tumors in organs amenable to percutaneous access, including liver and lung lesions.

Patient Selection: Candidates typically include patients with tumors that are technically accessible via percutaneous approach, those who are not surgical candidates due to comorbidities, and patients with limited metastatic disease suitable for local control.

Procedure Integration: The unified platform supports the complete treatment workflow from preoperative planning through ablation delivery, potentially reducing procedure complexity compared to using separate navigation and ablation equipment.

Regulatory Status

The NMPA “International First” designation indicates that the integrated navigation-ablation configuration represents a novel device category not previously approved in major global markets. The system was also the first product to enter and complete China’s innovative medical device special review pathway while being developed within the Hengqin Deep Cooperation Zone.

Clinical Significance

The integration of navigation and ablation capabilities addresses a practical workflow challenge in interventional oncology. Conventional approaches require coordination between separate navigation systems (for probe positioning) and ablation generators (for thermal delivery), each with distinct interfaces and operational requirements.

By consolidating these functions, the system may reduce setup complexity, simplify the procedure workflow, and improve the accuracy of ablation probe placement—particularly for targets that move with respiration where real-time tracking provides ongoing positional feedback.

For institutions already using TrueHealth’s puncture navigation systems, the ablation platform extends capabilities into the therapeutic domain while maintaining familiar navigation interfaces.

Frequently Asked Questions

What does “International First” designation mean?

NMPA’s International First designation indicates the product represents a novel device category not previously approved in major regulatory jurisdictions including China, the US, and Europe. For this system, the novelty lies in integrating robotic navigation with microwave ablation delivery in a unified platform.

How does this differ from conventional ablation equipment?

Traditional microwave ablation systems provide thermal energy delivery but rely on separate navigation equipment or freehand technique for probe positioning. This system integrates both functions, applying optical tracking and respiratory compensation to ablation probe placement.

What tumor types can be treated?

The system is designed for percutaneous microwave ablation of solid tumors in organs accessible via needle-based approaches, primarily liver and lung lesions. Patient selection follows established criteria for thermal ablation candidacy.