Privately held medical device company Stimwave Technologies has completed the SURF randomized clinical trial of first minimally invasive, miniature wireless spinal cord stimulator (SCS) system.
The prospective, randomized, multi-center clinical SURF RCT study is claimed to be the first ever pivotal trial conducted utilizing a wirelessly powered SCS system comparing several waveform options without a separate trialing device.
Stimwave stated that publication is pending for the data from the long-term clinical SURF study.
Stimwave’s multi-waveform automated WaveCrest iOS programming platform was tested for pain relief outcomes in patients with chronic back and leg pain. The system offers an appropriate waveform and frequency customized for each patient’s unique pain relief needs.
The company claims that in the two-arm study, high and low frequency, back and leg pain responders were over 92% and 86% respectively.
The study was performed in 100 patients at 7 US centers. It is claimed to have showed 100% implant placement success with no implant-related serious adverse events. After a 30 day initial trial period, patients were observed in a six month follow-up, in which it was observed that they experienced 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.
Stimwave chief medical officer Andrea Trescot said: “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.
“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 Freedom SCS System is a wireless, fully-programmable SCS neuromodulation device. It has been designed to be a less-invasive alternative for treating patients with chronic pain.