Stimwave Receives FDA Approval for High Frequency IDE
Stimwave Receives FDA Approval for High Frequency IDE Utilizing the World’s First and Only Eight-Electrode, Multi-Programmable Wireless Miniature Injectable Stimulator Prospective, Randomized, Multi-Center Non-Inferiority Study to Assess Pain Medication Reduction
MIAMI (June 9, 2015) – Stimwave Technologies Incorporated, a medical device manufacturer and independent research institute, today announced it has received FDA Investigational Device Exemption (IDE) approval to launch an 80-patient clinical trial utilizing the world’s first and only wireless miniature eight electrode, multi-programmable neurostimulator device for the relief of chronic back and leg pain.
Representing a life changing technological breakthrough for the more than 400 million people worldwide who endure daily chronic pain and may otherwise need to rely on pain medications, the Stimwave Freedom Spinal Cord Stimulation (SCS) System is the smallest neuromodulation device ever commercialized. 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 Stimwaves’s high frequency study using an external pulse generator. The randomized study will compare conventional stimulation programming settings of five to 1,500 Hz frequencies to those of a higher 10,000 Hz 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 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,” said Porter McRoberts, M.D., Holy Cross Hospital, from Fort Lauderdale, Florida, the principal investigator of the study. The study will begin enrollment this summer at sites throughout the U.S.
Stimwave’s revolutionary electroceutical device is based on a tiny, 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 anesthesia 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 utilizing this technology from a single outside source,” said Laura Tyler Perryman, CEO and chairman of Stimwave. “It truly is the most versatile stimulator product ever to be developed.”
“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,” said Dr. David Kloth, M.D., medical director of the Connecticut Pain Care Center and author of Pain Wise. “Coupled with the minimally-invasive nature of Stimwave products and the patient’s greater acceptance of an implant that is 95 percent smaller than other options, the Freedom SCS System is a welcome addition to the tools available to manage long term, chronic pain.”
Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management.