SPR Therapeutic won CE Mark approval for the Smartpatch Peripheral Nerve Stimulation system . The device is indicated for treatment of chronic shoulder pain for stretches up to thirty days. Essentially similar to a traditional electrical muscle stimulator (EMS), the device has electrodes that are close but don’t quite touch the peripheral nerves.
The company is currently looking to receive approval from the FDA for the Smartpatch to treat post-stroke and post-amputation pain.
SPR is sponsoring FDA approved multi-center, randomized controlled clinical trials to support FDA market clearance for use of the Smartpatch system for treating post-stroke shoulder pain and post-amputation pain in the U.S.
The Smartpatch system is intended to be used for up to 30 days. SPR’s clinical trials have reported that most patients have experienced longer lasting pain relief beyond the 30-day treatment period. The Smartpatch system uses a proprietary method of peripheral nerve stimulation to treat pain, with electrodes positioned in proximity to, but not directly contacting, peripheral nerves.