Biotronik Neuro will unveil new data from the BENEFIT-03 clinical study at the upcoming North American Neuromodulation Society (NANS) annual meeting (30 January–1 February 2025, Orlando, USA), with a recent press release from the company noting that these findings will highlight the “transformative potential” of its Prospera spinal cord stimulation (SCS) system.
The Prospera system integrates Resonance multiphase stimulation with automatic, objective, daily remote monitoring and proactive care to optimise management of SCS patients’ chronic pain, according to Biotronik.
The company’s recent release states that 24-month data on the system have revealed that participants experienced significant pain relief, along with better sleep, improved function and reduced opioid medication use. Patients and clinicians reported positive experiences with the Prospera SCS system’s remote monitoring and remote programming capabilities, which enabled rapid resolution of issues to optimise therapy, and reduced burdens for both patients and clinicians, the release adds.
Highlights from the 24-month interim data produced by BENEFIT-03—a prospective, multicentre study in Australia that is the “first and only” long-term clinical trial evaluating the impact of SCS with real-time remote monitoring in patients with chronic low back and/or leg pain—include:
- Significant pain relief—at 24 months, therapy responder rates (>50% pain reduction on visual analogue scale) were 86% for back pain, 89% for leg pain, and 82% for overall pain
- Improved daily function—mean daily pain intensity (numerical rating scale) was reduced to 1.8 at 24 months versus 6.6 at baseline, and function (Oswestry disability index) was improved with 73% of participants reporting minimal/moderate disability at 24 months versus 5% at baseline
- Reduced opioid usage—among baseline opioid users, 80% eliminated or reduced dosage >50% at 24 months
- Serious device- or procedure-related adverse events were rare, with only one such event being reported
“BENEFIT-03 results highlight the sustained benefits of the Prospera SCS system and demonstrate how its proactive care capabilities—enabled by automatic, objective daily remote monitoring and programming—significantly improve patient outcomes,” said Leonardo Kapural (Florida Atlantic University, Boca Raton, USA/Carolinas Pain Institute, Winston-Salem, USA). “These findings support the adoption of such monitoring technologies and proactive interventions as the standard of care in spinal cord stimulation therapy, given the potential for rapid identification and resolution of issues that help maintain patients’ therapeutic goals over time.”
Additional 24-month BENEFIT-03 results alluded to in Biotronik’s recent release include:
- Rapid issue resolution—remote monitoring detected SCS issues for all participants, enabling intervention in 2.9 days versus more than 7.2 days for standard in-clinic SCS care, with the most common issues being low device usage and therapeutic amplitude outside the prescribed setting
- Reduced patient time and costs—at 24 months, 95% of participants reported that remote adjustments saved money, and 100% said they allowed more time for daily activities. Clinicians reported remote management reduced staff burdens in the management of 82% of participants and estimated that remote care prevented an average of 5.4 in-office visits per participant through 24 months, with the highest-need participants avoiding an average of 12 visits, substantially reducing travel time and costs
“We’re encouraged to see the continued strong results over time with the Prospera SCS system, which demonstrate its potential to advance patient care and address the challenges SCS patients face,” said Todd Langevin, Biotronik Neuro president. “This evidence reinforces the growing body of research supporting proactive care and remote monitoring as effective strategies to optimise pain relief, and mirror the real-world benefits our customers report.”
