Image Credit: Biotronik
Biotronik received FDA approval for its Prospera™ Spinal Cord Stimulation System on March 31, 2023. The system is intended to treat chronic, intractable pain in the trunk or limbs. The Prospera SCS System includes a rechargeable IPG, SCS leads, a clinician programmer, a patient programmer, and an external trial pulse generator.
This weekend at NANS 2025 Biotronik presented 24-month intermediate data from its BENEFIT-03 prospective, multicenter clinical study in Australia. According to the press release, 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.”