Pulsante microstimulator for cluster headaches

1.What is it?

Pulsante SPG Microstimulator is a wireless device relieving cluster headaches as the only neuromodulation therapy currently available with published results.

The remote control interacts with a micro chip implant over the sphenopalatine ganglion to inhibit the pain pathway and here’s why the market is ready for Pulsante…

2. Why is it important?

Currently treatment is only aimed at symptom relief for cluster headaches. Prevention is an added benefit the Pulsante Microstimulator offers within the first few months and sustained for an entire year as indicated from the Pathway R-1 study on 85 patients.

  • 68% patients reported significant reduction in frequency of attacks and/or significant pain relief
  • 13, 600 attacks acutely treated over the course of the study
  • 42.9% reduction in cluster headaches at 12 months
  • side effects generally reported as mild- moderate

Safety – neurostimulation is well recognised for chronic pain treatment which allows the SPG Microstimulator to adapt the principle to help improve treatment for cluster headaches.

3. How does it work?

  • Almond sized micro-stimulator implant inserted at the sphenopalatine ganglion (SPG) during a 60-90 min oral surgical procedure leaving no visible scars
  • Minimally invasive surgery via a small incision in the mouth, upper gum behind molars
  • Wireless remote control provided for therapy as required
  • Hold control to the cheek when cluster headache pain felt
  • Microstimulator activated for as long as the remote control held at the site
  • SPG nerve bundle stimulation blocks pain pathways to the brain by sending interfering nerve signals via mild electrical signals
  • Once pain resides, the controller can be moved away from the face to stop therapy

References

All images in this article belong to Autonomic Technologies, Inc – except the featured image by MedX Creative Director; Jannat Alam.

  1. International Neuromodulation Society. Neuromodulation: An Emerging Field. (2016 Dec. 12) Retrieved from  http://www.neuromodulation.com/medical-therapy-overview
  2. Schoenen, et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: A randomized, sham-controlled study. Cephalalgia, 2013; 33:816-30
  3. Tung, et al. Surgical complications of the Le Fort I osteotomy – a retrospective review of 146 cases. Changgeng Yi Xuan Zag Zhao 1995; 18:102–107.
  4. Al-Din, et al. Sensory nerve disturbance following Le Fort I osteotomy. In J Oral Maxillofac Surd 1996; 25: 13–19.

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