FDAnews Device Daily Bulletin
Medical Devices / Research and Development

StimRelieve Receives IDE Approval to Launch Trial of Halo CFNS System

Dec. 3, 2015
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Medical device company StimRelieve has received IDE approval to launch a clinical trial of its StimRelieve Halo CFNS system.

The system is a small, implantable device for the treatment of refractory craniofacial neuropathic pain.  It has the ability to provide stimulation parameter frequencies to 10,000 Hz.

Implanted through a minimally invasive procedure, the system is based on wireless neuromodulation technology, and there is no implanted battery pack placed in the patient’s chest.

The aim of the study is to achieve sustained pain reduction of more than 50 percent — measured by VAS — at three months with no increase in medication.  — Michael Cipriano