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                                            Safety Information Article
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       Neurostimulation System: Pulsante SPG (Sphenopalatine Ganglion) Microstimulator
Autonomic Technologies, Inc.
 

Neurostimulation System: Pulsante SPG (Sphenopalatine Ganglion) Microstimulator
Autonomic Technologies, Inc.

Autonomic Technologies, Inc. developed the Pulsante SPG (Sphenopalatine Ganglion) Microstimulator System (also known as the ATI Neurostimulation System) to provide on-demand SPG stimulation therapy with the intention to relieve the debilitating pain of cluster headache. The Pulsante SPG System is a minimally-invasive, rechargeable, multi-channel, peripheral nerve stimulation system. The System includes:

The Insert. Pulsante SPG Microstimulator (ATI Neurostimulator), a microstimulator with an integral lead designed to fit the facial anatomy. The microstimulator is available in four sizes to accommodate a range of facial anatomies. The insert has CE-marked MR Conditional labeling for whole-body MRI.

The Remote Controller. A hand-held device with simple therapy controls that provides on-demand patient-controlled SPG therapy. Therapy settings are individualized and can be adjusted quickly by physicians using a programmer laptop.

Magnetic Resonance Imaging (MRI)

The ATI Neurostimulator is MR Conditional. It poses no known hazards in specified MRI environment with specified conditions of use.

Non-clinical testing has demonstrated the ATI Neurostimulator is MR Conditional. It can be scanned safely under the following conditions:

  • Static magnetic field of 3.0 Tesla spatial gradient field of 8 Tesla/meter
  • Maximum whole body averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning.

In non-clinical testing in a 3.0 Tesla MR scanner, the ATI Neurostimulator produced a temperature rise of less than 5.0°C at a maximum whole body averaged specific absorption rate (SAR) of 2 W/kg, as assessed by calorimetry for 15 minutes of MR scanning.

The image artifact extends approximately 40 mm from the device, including the lead, when scanned using the spin and gradient echo pulse sequence.

Refer to the ATI Neurostimulation System manuals for additional warnings and information for the use of the ATI Neurostimulation System.

The ATI Remote Controller is MR Unsafe. It is hazardous in all MRI environments.

Important Note to MR Healthcare Professionals: Different MRI guidelines may exist for different countries. Therefore, use the appropriate information for your country.

[MR healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MR procedure.]

References

www.ati-spg.com

www.ati-spg.com/wp-content/uploads/ATI-Implant-Manual-and-IFU-English-5131-B.pdf



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