BlueWind Medical has announced the completion of patient follow-up for a peripheral neuropathic pain (PNP) study. This study is intended to support CE mark application submission for multiple indications for the Reprieve wireless neuro-stimulation device, including pain management, epilepsy and sleep-apnea.
The study was successfully performed in four centres in Belgium and Poland with up to six months follow-up. Study results will be presented next month at the North American Neurostimulation Society (NANS) annual meeting in Las Vegas.
“Approximately 50% of patients with diabetic peripheral neuropathic pain cannot be sufficiently treated with pain medication alone.” says Van Buyten, the primary investigator of the study and chairman of the Multidisciplinary Pain Centre at the AZ Niklaas Medical Center. “The Reprieve system enables us to treat many of these patients and provide them with immediate relief.”
The Reprieve neurostimulator electrically stimulates the tibial nerve, supressing the patient’s painful sensations. The Reprieve unit is a miniature leadless device that can be implanted in a minimally invasive procedure under local anaesthesia. The device is designed to empower patients to take control of their therapy and decide when to use stimulation, based on actual pain.
“The future of neurostimulation is in miniaturisation and patient empowerment,” says Guri Oron, BlueWind’s CEO. “In order to treat most patients, devices that are significantly smaller and simpler to implant will be required.”