New Data Show Significant Pain Relief, Reduced Opioid Use, Decreased Patient Time and Cost Burdens with the ProsperaTM SCS System

24-month interim results from the first long-term study of SCS with automatic, objective, daily remote monitoring presented at NANS 2025 Annual Meeting

ORLANDO, Fla., Jan. 29, 2025 /PRNewswire/ -- BIOTRONIK Neuro will unveil new data from the BENEFIT-03 clinical study at the North American Neuromodulation Society (NANS) 2025 Annual Meeting. The findings highlight the transformative potential of its ProsperaTM Spinal Cord Stimulation (SCS) system.

This system integrates RESONANCE™ multiphase stimulation with automatic, objective, daily remote monitoring and proactive care* to optimize management of SCS patients' chronic pain.¹ The 24-month data 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 optimize therapy and reduced burdens for both patients and clinicians.

The 24-month interim data are from BENEFIT-03, a prospective, multicenter 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.

Highlights of the 24-month interim results include:

• Significant pain relief: At 24 months, therapy responder rates (>50% pain reduction by Visual Analog Scale) were 86% for back pain, 89% for leg pain, and 82% for overall pain.
• Improved daily function: Mean daily pain intensity (by Numerical Rating Scale) was reduced to 1.8 at 24 months vs. 6.6 at baseline, and function was improved with 73% of participants reporting minimal/moderate disability at 24 months (Oswestry Disability Index) vs. 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: Only one such event was 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, MD, PhD, Professor of Anesthesiology at Florida Atlantic University and Physician at Carolinas Pain Institute and Center for Clinical Research. "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 demonstrated:

• Rapid issue resolution: Remote monitoring detected SCS issues for all participants, enabling intervention in 2.9 days, vs. more than 7.2 days with standard in-clinic SCS care.² The most common issues were 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 optimize pain relief and mirror the real-world benefits our customers report."

About The Prospera Spinal Cord Stimulation System
The Prospera Spinal Cord Stimulation system – with remote monitoring and proactive care via the Embrace One Care Team – delivers RESONANCE™, the only multiphase stimulation paradigm available. BIOTRONIK Neuro is the first and only manufacturer to offer daily remote monitoring, automatic objective data transmission and remote programming in the SCS space. This system allows therapy adjustments in real time, reducing the need for frequent in-person visits. By facilitating faster issue identification and management, Prospera enables therapy optimization, which may improve long-term outcomes for patients with chronic intractable pain. The Prospera SCS system is FDA-approved and available in the U.S.

Remote Management of Spinal Cord Stimulation Devices for Chronic Pain
Spinal cord stimulation is a proven, widely used treatment for chronic pain, delivering electrical impulses to the spinal cord to modulate nerve activity and reduce pain signals. While clinical studies confirm its long-term effectiveness, real-world challenges like loss of efficacy and device explant remain prevalent.^3-11 Traditional SCS systems often require frequent in-office visits for reprogramming, resulting in therapy delays, patient travel burdens, and higher costs. 

Emerging expert recommendations highlight the potential benefits of SCS systems with remote monitoring capabilities, which enable timely adjustments, minimize in-person visits, and may improve long-term outcomes by enhancing therapy management and patient convenience.

About BIOTRONIK Neuro
BIOTRONIK Neuro is a division of BIOTRONIK, a leading medical device company that has been improving the lives of patients with heart and blood vessel diseases for decades. Leveraging BIOTRONIK's advanced cardiovascular technologies, BIOTRONIK Neuro has created a new approach to spinal cord stimulation (SCS) therapy management: one that's not just implanted, but truly connected to the needs of patients and providers. Our goal is to redefine relief for patients experiencing chronic pain and to optimize the SCS experience daily, and over the lifetime of patient therapy. BIOTRONIK Neuro is based in Lake Oswego, Oregon.

About BIOTRONIK
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.

For inquiries, contact:
Corporate Communications
[email protected]
+49 (0) 30 68905-1414

Beth Richman
(312) 806-8999

References

1. Naidu, R. K., Kapural, L., Li, S., Tourjé, C., Rutledge, J., Dickerson, D., & Lubenow, T. R. (2025). A Review of the Prospera Spinal Cord Stimulation System with Multiphase Stimulation and Proactive Care. Current pain and headache reports, 29(1), 25. https://doi.org/10.1007/s11916-024-01318-3
2. Amirdelfan K, Antony A, Levy R, et al. Health-related and Economic Impacts of Clinic Visit Burdens for Spinal Cord Stimulation Patients and Caregivers. Poster presented at PSPS; September 16-18, 2022; Las Vegas, NV.
3. Deer TR, Slavin KV, Amirdelfan K, et al. Success using neuromodulation with BURST (SUNBURST) study: results from a prospective randomized controlled trial using a novel burst waveform. Neuromod. 2018;21(1):56-66.
4. North J, Loudermilk E, Lee A, et al. Outcomes of a multicenter, prospective, crossover, randomized controlled trial evaluating subperception spinal cord stimulation at ≤1.2 kHz in previously implanted subjects. Neuromod. 2020;23:102-108.
5. Mekhail N, Levy RM, Deer TR, et al. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomized, controlled trial. Lancet Neurol. 2020;19(2):123-134.
6. Fishman M, Cordner H, Justiz R, et al. Twelve-month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain. Pain Practice. 2021;21:912-923.
7. Kapural L, Yu C, Doust MW, et al. Novel 10-kHz high-frequency therapy (HF10 therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain. Anesthesiology. 2015;123(4)851-860.
8. Hayek SM, Veizi E, Hanes M. Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromod. 2015;18:603-609.
9. Pope JE, Deer TR, Falowski S, et al. Multicenter retrospective study of neurostimulation with exit of therapy by explant. Neuromod. 2017;20(6):543-552.
10. Simopoulos T, Aner M, Sharma S, Ghosh P, Gill JS. Explantation of percutaneous spinal cord stimulator devices: a retrospective descriptive analysis of a single-center 15-year experience. Pain Medicine. 2018;0(0):1-7.
11. Hagedorn JM, Lam CM, D'Souza RS, et al. Explantation of 10 kHz spinal cord stimulation devices: a retrospective review of 744 patients followed for at least 12 months. Neuromod. 2021;24:499-506

Disclaimer: Embrace One is a support platform intended to help manage a patient's experience with spinal cord stimulation. It is not intended to be used for medical diagnosis or medical treatment.

*Proactive Care: BIOTRONIK Neuro's remote support team may reach out to patients to ensure proper usage of the SCS system based on remotely monitored data. BIOTRONIK Neuro does not provide health advice or clinical actions outside the scope of SCS proper usage. This product support is not a replacement for the patient's responsibility to communicate any medical questions or concerns with the physician's office.

^†With successful data transmission, patient therapy data is available up to the prior 24-hour period

SOURCE BIOTRONIK