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The Thermoguide Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery for wavelengths of 1064nm.

When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Thermoguide Therapy System can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.

The Thermoguide Therapy System is compatible with 1.5T and 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of analysis using the Thermoguide Therapy System

The Thermoguide Therapy System consists of the following three components:

1. Mobile Laser Unit
2. Laser applicator and introducer
3. Thermoguide Workstation

The Thermoguide Therapy System can be used for soft tissue laser ablation procedures by appropriate trained medical professionals only. The Thermoguide Therapy System has received FDA clearance for use with 3T magnetic resonance (MR) scanners (K214125). This submission expands the approval to include both 3T and 1.5T MR field strengths.

The system consists of a medical laser apparatus (Mobile Laser Unit), single use sterile devices (Laser applicator and introducer) and a workstation with software (Thermoguide Workstation) for extracting temperature maps from magnetic resonance (MR) images to calculate thermal dose in the tissue.

The Thermoguide Therapy System can be used for soft tissue laser ablation procedures using MR image guidance in minimal invasive procedures under local or general anesthesia. The system is optimized with advanced functions to control and monitor tissue temperatures within the ablation volume and surrounding tissue.

The Mobile Laser Unit is provided with a laser generator operating at the wavelength of 1064 nm, continuous wave. The generated laser light is locally applied by means of a single use applicator kit (Laser applicator and introducer) through a less invasive surgical or percutaneous procedure. The energy within the laser light is absorbed by the tissue resulting in increased tissue temperature that necrotizes or coagulates soft tissue.

The Laser applicator is a 12 m long optical fiber allowing the laser generator to be placed in the MRI control room. The treatment is monitored using the Thermoguide Workstation to measure temperature changes and estimate thermal damage resulting from the induced temperature increase.

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