Clinical trial results showed that the world’s first wireless, fully programmable neuromodulation system (Freedom SCS System; Stimwave Technologies, Pompano Beach, FL) provided significant relief for patients suffering from chronic back and leg pain.
In the trial, 92% of patients (n = 100) had pain relief from high-frequency stimulation and 86% had pain relief from low-frequency stimulation. Sustainable visual analog scale (VAS) pain reduction was 76% at the 6-month endpoint. These results met or exceeded previous RCT results with implantable pulse generators. The system can deliver low-frequency, high-frequency, tonic, and burst waveforms, and study participants utilized those options to achieve pain relief.
The SURF (NCT02514590) randomized controlled trial (RCT) was the first-ever pivotal study conducted using a miniaturized, wirelessly powered spinal cord stimulator (SCS) system that compared a variety of waveform options without a separate trialing device. There were no serious adverse events and 100% implant placement success. After an initial 30-day trial period with the permanently implanted device, and during a 6-month follow-up visit, patients experienced significant improvement in VAS pain scores.
“Stimwave has shown through this RCT the advantages of effectively utilizing wireless technology to deliver the proper dosing and programming versatility to pain sufferers,” said Andrea Trescot, MD, FIPP, chief medical officer of Stimwave. “This allows the patient to cycle between waveforms, tailoring the stimulation to that individual patient.”
Aziz Shaibani, MD
James P. Orengo, MD, PhD; and David R. Murdock, MD