Stimwave Announces Completion of the SURF Randomized Clinical Trial of First Minimally Invasive, Miniature Wireless SCS System
Positive Six-Month Results Demonstrate Substantial Benefits over Historical Conventional Battery Legacy System Reported Outcomes
POMPANO BEACH, FLORIDA (January 16, 2019) – Stimwave Technologies, the leading innovator of wireless medical device bioelectronic technology, today announced pending publication and completion of long-term clinical data from the SURF study.
The SURF RCT study, a prospective, randomized, multi-center clinical trial was the first ever pivotal study conducted utilizing a wirelessly powered Spinal Cord Stimulator (SCS) system comparing a variety of waveform options without a separate trialing device. Without limitations on power delivery classically associated with implantable batteries and combined with the flexibility in programming utilizing Stimwave’s proprietary multi-waveform automated WaveCrestTMiOS programming platform, the study participants were able to leverage the most state of art capabilities and options available in the industry to optimize their pain relief outcomes and dial in the appropriate waveform and frequency customized to their unique pain relief needs. Notable, in the two-arm study, high and low frequency, back and leg pain responders were over 92% and 86% respectively.
“Unique among neurostimulation systems, Stimwave has shown through this RCT the advantages of effectively utilizing wireless technology to deliver the proper dosing and programming versatility to pain suffers. In addition, using their wireless WaveCrest programming system, Stimwave can deliver a multitude of waveforms (low frequency, high frequency, tonic, and burst) to the same patient, using the same hardware, without the need for a separate trialing procedure to be performed. This allows the patient to cycle between waveforms, tailoring the stimulation to that individual patient,” said Andrea Trescot, MD, FIPP, Chief Medical Officer of Stimwave. “All of these options allow clinicians to use the stimulation pattern that works best for that patient. This is personalized, individualized medicine at its best.”
The study enrolled 100 patients at 7 U.S. centers. Nagy Mekhail M.D., of the Cleveland Clinic served as national principal investigator of the study. The SURF study demonstrated 100% implant placement success and no implant related serious adverse events. After an initial 30-day trial period with the permanent implanted device, and throughout a six-month follow-up, treated patients experienced statistically significant improvement in VAS scores in both arms of the study. Results met or exceeded historical reported RCT studies with IPGs, with sustainable VAS pain reduction in the active high frequency arm at over 76% in the SURF study at the 6 months end point.
“We are pleased with the positive results from the SURF study and thankful to all of the investigators and patients who participated in this important research,” said Laura Tyler Perryman, Co-Founder and CEO of Stimwave. “We look forward to further exploring the various advantages of wireless power delivery and developing the body of evidence to enhance patient’s lives without excess burden, compilations and a lifetime of battery changes.”
Study investigator Aaron Calodney, MD, FIPP of Precision Spine Care Tyler Texas, is presenting the SURF 6 month data at the North American Neuromodulation Society meeting January 18, 2019 in Las Vegas, Nevada and at a private invitation only event the same evening.
The Freedom SCS System is the world’s first wireless, fully-programmable SCS neuromodulation device providing a life-changing technological breakthrough for the more than 90 million people in the U.S. who endure daily chronic back and leg pain. The Freedom stimulators are designed to be a less-invasive alternative to treat patients with chronic pain, typically that would otherwise warrant surgery to place paddles leads or large IPGs, which have been reported to have substantial complications in at least a third of all patients. The Freedom SCS System is FDA Cleared and commercially available in the US at the low frequency parameters (frequencies at or below 1,500 Hz) demonstrated in the study. While the Freedom SCS System’s high frequency stimulation (frequencies from 1,500 Hz to 10 kHz) is not yet marketed in the United States, these parameters are commercially available in the European and Australian markets. The safety and effectiveness of the Freedom SCS System’s high frequency stimulation parameters is in review with the FDA for market clearance.
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. www.stimwave.com
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Press contact: Rosemary O’Brien and Sarah Rogers, Glodow Nead Communications, (415) 394-6500, [email protected]