Interim Six-Month Results from a Prospective Multicenter Study of Multiphase SCS System With Remote Device Management

Marc Russo MD,¹ James Yu MD,² Vahid Mohabbati MD,³ Kasra Amirdelfan MD,⁴ Leonardo Kapural MD PhD,⁵ Paul Verrills MBBS⁶

¹Hunter Pain Specialists, Broadmeadow NSW, Australia; ²Sydney Spine and Pain, Hurstville NSW, Australia; ³Sydney Pain Management Centre, Parramatta NSW, Australia; ⁴Boomerang Healthcare, Walnut Creek, CA; ⁵Carolinas Pain Institute, Winston-Salem, NC; ⁶Monash House Private Hospital, Metro Pain Group, Clayton VIC, Australia

INTRODUCTION

• A proprietary multiphase spinal cord stimulation (SCS) therapy has previously been assessed preclinically and in a short-term clinical trial
• In a large animal model, multiphase SCS produced a larger area of hemodynamic response that penetrated deeper into the dorsal horn and provided greater coverage of the spinal cord versus other SCS modalities¹
• Published results from BENEFIT-02 (NCT03594266), a prospective feasibility study, demonstrated that multiphase SCS resulted in significant pain relief, improvements in sleep quality, and increased physical activity with minimal adverse events²
• While most SCS systems require in-person programming, emerging technologies with remote device monitoring and/or programming offer the potential to improve patient care and outcomes through the proactive and timely identification/resolution of SCS device and therapy-related issues^3-5
• In March 2023, the US Food and Drug Administration approved the Prospera^TMSCS System* as an aid in the management of chronic, intractable pain in the trunk and/or limbs (BIOTRONIK SE & Co. KG, Berlin, Germany)
• The system features RESONANCE^TM, the first and only multiphase stimulation paradigm paired with proactive care, a patient-centric care model made possible by offering automatic, objective, daily remote monitoring, remote programming, and ongoing management and support

OBJECTIVE

• To describe interim data from BENEFIT-03 (NCT04683718), the first long-term study of an SCS system with a proprietary multiphase stimulation paradigm and automatic daily transmission of objective device monitoring data with remote programming

METHODS

• BENEFIT-03 is a prospective, multicenter, single-arm study with 24-month follow-up conducted at up to 5 Australian sites with Human Research Ethics Committee approval and participant informed consent, evaluating effectiveness and safety of the Prospera SCS System* (Figure 1)
  • Additional study data are detailed in 2 other ASRA posters presented by L. Kapural

INTERIM 6-MONTH RESULTS†

Participants and Baseline Characteristics

• From Sept 2021 to Sept 2022, 55 participants were consented and assessed for eligibility; of these, 46 were provisionally enrolled, 34 trialed, and 31 implanted with the Prospera SCS System* (mean implant duration: 310 days [range: 42–556])
• Participants had high baseline disease burden, with mean pain duration over 10 years and 56.5% taking opioid analgesics (Table 1)
• Participants with baseline travel data (n=43) reported a mean of 16 office visits over the 12 months prior to enrollment for their chronic pain management
• Visits required a mean travel time of 109 minutes (n=44), resulting in high costs and affecting work

Pain Intensity and Responders

• At 6 months, 82–93% of participants were responders (with ≥50% pain reduction from baseline in back, leg, or overall pain) and 48–71% had ≥80% pain reduction from baseline (Figure 2)
• Back, leg, and overall pain mean VAS scores significantly improved from baseline (76.8–79.7) to month 3 (16.6–25.4) and month 6 (11.9–20.2) (Figure 3)

Oswestry Disability Index and Opioid Medication Usage

• Oswestry Disability Index (ODI) scores improved from baseline to month 6, indicating less severe disability; categorization by ODI score is shown in Figure 4
• Among those with opioid usage at baseline (n=15/23; 48.2 mg/d morphine equivalent units):
  • By 3 months, 47% eliminated opioids and 60% eliminated/reduced opioid dose by ≥50%
  • By 6 months, 80% eliminated opioids and 87% eliminated/reduced opioid dose by ≥50%

PGIC and PROMIS-29

• Most participants (85%) said their stimulator made their life better or a great deal better (Figure 5)
• All domains of the PROMIS-29 questionnaire were improved from baseline to month 6 (Figure 6)

Safety

• Only 1 device- or procedure-related serious adverse event was reported (Table 2)

CONCLUSIONS

• BENEFIT-03 interim results provide evidence supporting safety and effectiveness of multiphase stimulation with remote device management and proactive care
• At 6 months, in-clinic VAS scores indicated highly effective chronic pain relief: 82% of participants were responders and 54% were high responders
• Consistent with effective pain relief, 88% of participants transitioned from severe/crippling disability to moderate/minimal disability
• Of opioid users, 87% eliminated use or reduced their dose by ≥50% at 6 months
• Serious adverse events related to the device or procedure were rare, with only 1 event reported

Proactive Care: BIOTRONIK Neuro’s remote support team may reach out to patients to ensure proper usage of the spinal cord stimulator based on remotely monitored data. BIOTRONIK Neuro does not provide health advice or clinical actions outside the scope of spinal cord stimulator 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.

*Approved in the US only; not commercially available outside the US.

†At the time of this interim analysis not all participants had completed 3- and 6-month follow-ups. Outcomes may change as additional participant data are collected.

AUTHOR DISCLOSURES

M. Russo has historical minor equity holding in SPR Therapeutics and options in Saluda Medical and Presidio Medical. J. Yu has consulted for Abbott, Nevro, Medtronic, Boston Scientific and participated in research for Nevro, Boston Scientific, Medtronic, Saluda, Biotronik, and Nalu. V. Mohabbati has consulted for Medtronic, Abbott, Saluda, Nevro, and participated in research for Nevro, Medtronic, Abbott, Nalu, and Saluda. K. Amirdelfan has consulted for Medtronic, Boston Scientific, Nevro, Biotronik, and Nalu (minor options). L. Kapural has consulted for Nevro, Abbott, Medtronic, Nalu, Saluda, and Biotronik and participated in research for Nevro, Medtronic, Gimer Medical, Neuros, Saluda, Biotronik, and SPR Therapeutics. P. Verrills has consulted for Presidio, Biotronik, Saluda, and Nalu and has participated in research with Biotronik and Presidio.

REFERENCES

1. Slee SJ et al. Functional Ultrasound Reveals Activation Properties of Clinical Spinal Cord Stimulation Therapy [INS abstract O011]. Neuromod. 2022;25(7):S41

2. Kapural L et al. Neuromod. Online ahead of print Aug 16, 2023. doi:10.1016/j.neurom.2023.05.006.

3. Staats P et al. Neuromod. Online ahead of print Aug 25, 2023. doi:10.1016/j.neurom.2023.07.003.

4. Deer TR, Esposito MF, Cornidez EG, et al. J Pain Res. 2021;14:3259–3265.

5. Lu Y, Xie D, Zhang X, et al. Front Neurosci. 2020;14:594696.

This study is sponsored by BIOTRONIK • Writing and editorial assistance were provided by Prescott Medical Communications Group (Chicago, IL), a contractor of BIOTRONIK NRO, INC.

 

Presented at the American Society of Regional Anesthesia 22nd Annual Pain Medicine Meeting • November 10–11, 2023 • New Orleans, LA