Stimwave Technologies has received US Food and Drug Administration investigational device exemption (IDE) approval to launch an 80-patient clinical trial utilising the company’s Freedom spinal cord stimulation system.
Stimwave says that its Freedom system is the “smallest neuromodulation device ever commercialised”. It is now available in an eight-electrode array, which provides additional programming and placement options for patients, including the use of high-frequency stimulation.
The FDA has also approved Stimwave’s high frequency study using an external pulse generator. The randomised study will compare conventional stimulation programming settings of five to 1,500Hz frequencies to those of a higher 10,000Hz frequency to measure pain relief outcomes, patient preferences, reduction in opioid usage, and reduction in adverse events, compared with conventional internal pulse generator (IPG) products. Recent studies have shown that high frequency has a greater effect on pain relief and quality of life, and it is expected to be effective in providing therapeutic, long-term pain relief for chronic back pain.
“This study will represent for the first time an injectable high frequency platform utilised 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,” said Porter McRoberts, Holy Cross Hospital, from Fort Lauderdale, USA, the principal investigator of the study. The study will begin enrolment this summer at sites throughout the USA.
Stimwave’s electroceutical device is based on an injectable microchip that delivers small pulses of energy to electrodes near surrounding nerves. The device will be used in both cohorts of the study. It is implanted in an outpatient procedure through a standard needle with no need for general anaesthesia or a large surgical incision, which has distinct advantages over conventional IPGs, which are both more expensive and significantly more invasive.
“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 utilising this technology from a single outside source,” said Laura Tyler Perryman, chief executive officer and chairman of Stimwave.
“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 customise the device placement and programming features to the needs of the patient is a capability that the industry has been in great need of,” said David Kloth, medical director of the Connecticut Pain Care Center. “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 system is a welcome addition to the tools available to manage long term, chronic pain.”