Completion of long-term clinical data from the SURF study (Stimwave Technologies) has been announced. The results are now pending publication.
The SURF RCT study, a prospective, randomised, multicentre clinical trial was the first ever pivotal study conducted utilising a wirelessly powered Spinal Cord Stimulator (SCS) system comparing a variety of waveform options without a separate trialling device. The study participants were able to optimise their pain relief outcomes and dial in the appropriate waveform and frequency customised 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.
The study enrolled 100 patients at 7 US centres. Nagy Mekhail, 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.
Study investigator Aaron Calodney, 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, USA and at a private invitation only event the same evening.
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 USA 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.