Biotronik said that new 24-month interim data from the BENEFIT-03 trial indicates the potential of its Prospera Spinal Cord Stimulation (SCS) system to provide significant pain relief and improve patient outcomes.

The Prospera SCS system is an implanted spinal cord stimulation device to treat long-term, intractable pain in the trunk or limbs. It is intended to optimise chronic pain management.

The system offers the RESONANCE stimulation paradigm, which is a multiphase stimulation approach, along with remote monitoring and proactive care through the Embrace One Care Team.

It was approved by the US Food and Drug Administration (FDA) in 2023. In October 2023, Biotronik announced positive outcomes from the BENEFIT-02 trial.

Biotronik neuro president Todd Langevin said: “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.

“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.”

BENEFIT-03 is a multicentre study in Australia. It is said to be the first long-term clinical trial to evaluate the impact of SCS with real-time remote monitoring in patients with chronic low back and/or leg pain.

The data indicated significant pain relief, better sleep, improved function, and reduced opioid medication use.  

At 24 months, therapy responder rates were 86% for back pain, 89% for leg pain, and 82% for overall pain, showing substantial pain relief.

Daily function also improved, with the mean pain intensity dropping from 6.6 to 1.8 at baseline, and 73% of participants reported minimal or moderate disability.

Opioid use was significantly reduced, as 80% of baseline opioid users either eliminated or reduced their dosage by more than 50%.

Both patients and clinicians reported positive experiences with the Prospera SCS system’s remote monitoring and programming features, which facilitated quick issue resolution, optimised therapy, and reduced burdens on all parties.

Additional 24-month BENEFIT-03 results showed significant improvements in issue resolution. Remote monitoring detected issues for all participants, enabling early intervention compared to standard in-clinic care.

It also reduced patient time and costs. At 24 months, 95% of participants reported savings, while 100% said remote adjustments allowed more time for daily activities.

Clinicians noted that remote management eased staff burdens, reducing in-office visits per participant and cutting down on travel time and costs.