Biotronik Neuro has announced that results from the BENEFIT-02 trial—the “first of its kind” to clinically evaluate a multiphase stimulation paradigm—support the effectiveness of RESONANCE multiphase stimulation used in the company’s Prospera spinal cord stimulation (SCS) system for the treatment of patients with chronic pain.
The results from BENEFIT-02 have been published in Neuromodulation: Technology at the Neural Interface by principal investigator Leonardo Kapural (Carolinas Pain Institute and Center for Clinical Research, Winston-Salem, USA) and colleagues.
“Former studies have shown good results with previously commercialised SCS technology, yet in practice we are still looking for ways to reduce patient burden and improve outcomes. This study is particularly exciting because it is the first in a series to explore how to do that,” said Kapural.
A Biotronik press release states that, in contrast with other currently available SCS therapies, RESONANCE requires less power and uses a proprietary, integrated circuit design to deliver a continuous, spatially and temporally distributed therapeutic pulse pattern across the spinal cord.
BENEFIT-02—a prospective, multicentre, randomised, single-blind, feasibility study—is part of a comprehensive research programme supporting Biotronik’s Prospera SCS system, which received US Food and Drug Administration (FDA) approval in March 2023. BENEFIT-02 assessed the safety and effectiveness of Biotronik’s new charge-distributed multiphase stimulation paradigm during an extended SCS trial. It included participants with chronic low back and/or leg pain, and a baseline numerical rating scale (NRS) score for overall pain intensity ≥6.
After a successful commercial SCS trial, participants were randomised to multiphase SCS therapy, receiving approximately 600–1500Hz (therapy A) or 300–600Hz (therapy B) of stimulation. Following washout, therapy was delivered via an investigational external pulse generator and existing leads during an 11- to 12-day testing period.
Among the 65 patients completing the study, there was no statistically significant difference in mean NRS reduction or percentage pain relief between multiphase therapies A and B. In the at-home setting, 63.9% of participants reported greater pain relief with multiphase than with commercial SCS therapy, along with an increase in average sleep quality and physical activity. Additionally, adverse events were rare, and none were classified by investigators as serious. On average, multiphase therapy required less power than its commercial counterparts.
“The short-term multiphase stimulation results here—combined with early findings from the long-term BENEFIT-03 study—show great promise for the future of SCS,” Kapural stated.
BENEFIT-03 is the first long-term evaluation of the Prospera SCS system with RESONANCE multiphase stimulation alongside automatic, daily, objective device monitoring, and remote programming. Interim data from the ongoing study in Australia support Biotronik’s proactive care approach to SCS therapy, the company claims. Six-month results were recently presented at the American Society of Pain and Neuroscience (ASPN) annual conference (13–16 July 2023, Miami, USA), and demonstrated significant pain reduction in both in-clinic and at-home settings with less severe disability.
“As we await additional data from our BENEFIT-03 study, we are excited to see these initial data on the long-term effects of our SCS system,” said Biotronik Neuro president Todd Langevin. “We developed Prospera to offer patients sustainable pain relief—and we believe its proactive care model will have a clinically meaningful impact on lowering long-term failure rates and reducing the service burden of SCS.”