The European Union has granted CE mark certification to a peripheral nerve stimulation (PNS) device developed by the US-based SPR Therapeutics for the minimally-invasive treatment of chronic shoulder pain.
Using electrodes placed in proximity of the peripheral nerves, the non-narcotic, reversible Smartpatch system stimulates nerves and provides relief from acute and chronic musculoskeletal pain.
The neurodevice firm also said the device, which is intended to be used for up to 30 days, fills a treatment gap for a minimally-invasive alternative between pharmaceuticals or injections and major surgery.
During the company’s clinical studies the PNS device has showed significant pain relief beyond the 30-day treatment period.
The company will use the CE mark to further develop clinical data and clinician advocacy in support of shoulder pain indication through European orthopedic, pain management, physical medicine and rehabilitation channels, and to expand to other markets in the future.
Clinical investigations on additional pain indications in the orthopedic and rehabilitation markets are also being carried out, said the company.
SPR Therapeutics president and CEO Maria Bennett said; "Toward this end, we are in discussions with corporate strategic partners to commercialise Smartpatch outside the United States."
In order to achieve FDA clearance to market the product in the US is sponsoring multi-centre, randomised controlled clinical trials of Smartpatch.
SPR’s product portfolio also includes the fully-implantable Micropulse system, which uses the company’s platform technology for long-term pain management.
