LS Series MRI-Guided Laser Ablation System
The LS Series Magnetic Resonance-Guided Laser Ablation System (LITT) represents a milestone achievement in Chinese medical device innovation. Approved by NMPA in April 2023, this system became the first and only domestically-developed brain laser ablation platform authorized in China, offering a new minimally invasive treatment option for patients with drug-resistant epilepsy and brain tumors.
Product Overview
Laser interstitial thermal therapy (LITT) has emerged globally as a significant approach to treating focal brain lesions without conventional craniotomy. The technology combines real-time MRI thermometry, predictive ablation modeling, stereotactic guidance, and controlled laser delivery to achieve precise tissue destruction while monitoring treatment progress in real-time.
Sinovation’s LS Series brings this advanced treatment modality to Chinese patients, enabling treatments for conditions previously requiring open surgery or considered inoperable. The system marks a strategic expansion beyond surgical navigation into therapeutic intervention, establishing Sinovation’s platform as a broad solution for brain disease treatment.
Key Features
The LS Series is China’s first domestically approved brain laser ablation system, using a semiconductor laser with real-time MRI thermometry to treat drug-resistant epilepsy and deep tumors through a 3mm burr hole.
Real-Time MRI Temperature Monitoring: Continuous intracranial temperature visualization during ablation enables precise control of thermal delivery and immediate feedback on treatment progress.
Predictive Thermal Modeling: Ablation effect estimation allows surgeons to plan and visualize expected tissue destruction before and during treatment.
Stereotactic Integration: Compatible with Sinovation’s robotic platforms and navigation systems for accurate laser fiber placement.
Semiconductor Laser Source: The MRI-compatible semiconductor laser delivers controlled thermal energy through a precisely positioned fiber optic catheter.
Disposable Laser Fiber Kit: Single-use laser fiber assemblies ensure consistent performance and eliminate cross-contamination risks.
MRI Compatibility: Full integration with MRI environments, requiring no special modifications to standard imaging equipment.
Technical Specifications
Approved by NMPA in April 2023 as China’s first brain LITT system, the LS Series delivers semiconductor laser energy through a percutaneous fiber while continuous MRI thermometry monitors ablation in real time.
| Parameter | Specification |
|---|---|
| System Components | MRI-compatible laser unit, monitoring workstation, disposable fiber kit |
| Imaging Guidance | Real-time MRI thermometry |
| Thermal Monitoring | Continuous intracranial temperature mapping |
| Laser Type | Semiconductor |
| Fiber Delivery | Percutaneous stereotactic placement |
Clinical Applications
Drug-Resistant Epilepsy: For patients with focal epilepsy refractory to medical management, LITT provides a minimally invasive alternative to open resection. The system enables precise ablation of seizure foci identified through SEEG evaluation, with particular value for mesial temporal sclerosis, hypothalamic hamartomas, and periventricular nodular heterotopia.
Brain Tumors: Patients with tumors in deep or eloquent brain regions who are poor candidates for open surgery may benefit from LITT ablation. The approach provides tumor control with minimal disruption to surrounding functional tissue.
Radiation Necrosis: Following stereotactic radiosurgery, some patients develop symptomatic radiation necrosis. LITT offers a treatment option for these challenging lesions when medical management fails.
Lesions in High-Risk Locations: Pathology located near the brainstem, motor cortex, speech areas, or deep nuclei may be treatable with LITT when open surgical approaches carry unacceptable risk.
The minimally invasive nature of LITT—typically involving a 3mm burr hole rather than craniotomy—significantly reduces surgical trauma, postoperative pain, and hospital stay compared to conventional approaches.
Regulatory Status
| Region | Status | Date | Notes |
|---|---|---|---|
| China (NMPA) | Approved | April 2023 | First domestic LITT system |
| United States (FDA) | Not Applied | - | - |
| European Union (CE) | Not Applied | - | - |
Frequently Asked Questions
What conditions can be treated with the LS Series LITT?
The system is primarily indicated for drug-resistant epilepsy and brain tumors, particularly lesions in deep or eloquent brain regions unsuitable for open surgery. Applications include mesial temporal sclerosis, hypothalamic hamartomas, radiation necrosis, and select primary and metastatic brain tumors.
How does LITT compare to conventional brain surgery?
LITT requires only a small burr hole (approximately 3mm) compared to full craniotomy, resulting in reduced surgical trauma, shorter hospital stays, and faster recovery. The procedure is performed under real-time MRI monitoring rather than direct visualization, enabling treatment of deep lesions with minimal disruption to overlying brain tissue.
Is this the first LITT system in China?
Yes. Sinovation’s LS Series became the first and only domestically-developed brain LITT system approved in China when it received NMPA authorization in April 2023. Prior to this approval, LITT procedures in China required imported equipment.
How is the laser fiber positioned?
The laser fiber is placed through a small stereotactic burr hole using robotic or frame-based guidance. Sinovation’s surgical robots (Sinobot X1, Q300) can provide the stereotactic positioning for fiber placement, creating an integrated workflow from planning through ablation.
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Sources
Publicly available references used for the data on this page. See data methodology for verification standards.
