The BENEFIT-02 trial evaluates the Resonance multiphase stimulating paradigm used in the Neuro Prospera system. It looked at the safety and effectiveness of the stimulator in treating patients with chronic pain.
Contrary to other currently available SCS therapies, Resonance requires less power and uses a proprietary integrated circuit design, according to Biotronik. It delivers a continuous, spatially and temporarily distributed therapeutic pulse pattern across the spinal cord.
Biotronik’s prospective, multicenter, randomized, single-blind feasibility study included participants with chronic low back and/or leg pain. They presented a baseline numerical rating scale (NRS) for overall pain intensity greater to or equal to six. After a successful commercial SCS trial, Biotronik randomized patients to multiphase therapy. Following washout, patients received therapy from an investigational external pulse generator and existing leads over an 11-12-day testing period.
In 65 patients who completed the study, it saw no statistically significant difference in mean NRS reduction or percent pain relief between multiphase therapies. In the at-home setting, 63.9% of participants reported greater pain relief with multiphase therapy compared to commercial SCS. They also reported an increase in average sleep quality and physical activity.
Biotronik said adverse events were rare, with none classified by investigators as “serious.”
The BENEFIT-02 trial constitutes part of a research program supporting the Biotronik Prospera SCS system. Prospera received FDA approval earlier this year. The company also said it has promising early findings from its long-term BENEFIT-03 study.
BENEFIT-03 evaluates Prospera with Resonance multiphase stimulation, automatic, daily, objective device monitoring and remote programming. Interim six-month results showed 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’re 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.”
