Stimwave Technologies said yesterday it won FDA investigational device exemption clearance to test an 8-electrode version of its wireless miniature neurostimulator device for the relief of chronic back and leg pain.
Miami, Fl.-based Stimwave said the FDA also approved a study of the device using high frequency treatments through an external pulse generator.
“This study will represent for the 1st time an injectable high frequency platform utilized with different parameter settings to truly assess the patient response and the best mechanism to enable long-term control of chronic pain and ability to reduce opioid dependency,” principal investigator of the study Dr. Porter McRoberts of Ft. Lauderdale, Fl.’s Holy Cross Hospital said in a press release.
Stimwave’s device is based on an injectable microchip designed to deliver pulses of energy to electrodes near surrounding nerves, the company said. The surgery to implant the device is minimally invasive, and uses a standard needle for insertion.
“This device is capable of a multitude of programming options and configurations, high frequency, tonic stimulation, multiple approaches to placement due to the small size; furthermore, there is no limit on how many electrodes can be powered utilizing this technology from a single outside source. It truly is the most versatile stimulator product ever to be developed,” Stimwave CEO Laura Perryman said in prepared remarks.
The trial is slated to begin patient enrollment in U.S. centers this summer, Stimwave added.
“The unique Stimwave platform provides greater versatility for chronic pain patients with additional options for treatment all within one system. Since each patient is unique and each case presents with different issues, the ability to customize the device placement and programming features to the needs of the patient is a capability that the industry has been in great need of. Coupled with the minimally-invasive nature of Stimwave products and the patient’s greater acceptance of an implant that is 95% smaller than other options, the Freedom spinal cord stimulator system is a welcome addition to the tools available to manage long term, chronic pain,” medical director of the Connecticut Pain Care Center Dr. David Kloth said in a prepared statement.
Last December Stimwave launched a clinical trial of its wireless neuromodulation anti-pain device for treating chronic, non-specific-origin lower back pain.