Stimwave today touted six-month data from a trial of its minimally invasive spinal cord stimulator system.
The company’s pivotal Surf trial compared a variety of waveform options without the need for separate trial devices. Stimwave reported that in the high and low frequency groups, back and leg pain responders were more than 92% and 86%, respectively.
The 100-patient study had 100% implant placement success, according to Stimwave, and no implant-related serious adverse events. Following a 30-day trial period with the implanted device and a six-month follow-up, participants experienced statistically significant improvement in VAS scores in both arms of the trial.
“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,” CMO Dr. Andrea Trescot said in prepared remarks.
Stimwave also touted that the study results met or topped historical reported RCT studies with neurostim devices. Specifically, researchers reported sustainable VAS pain reduction in the active high-frequency group of more than 76% at the six-months endpoint.
“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,” co-founder & CEO Laura Tyler Perryman added. “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.”
The company’s Freedom SCS system is available in the U.S. with frequencies at or below 1,500 Hz. High-frequency stimulation with the Freedom SCS system is not available in the U.S., but it is cleared in Europe and Australia. The FDA is reviewing the safety and efficacy of the system’s high-frequency parameters.
In November last year, Stimwave won FDA 510(k) clearance for an Apple (NSDQ:AAPL) iOS device version of its WaveCrest Mobile platform patient controller application for pain management.
