Help your Spinal Cord
Stimulation (SCS) patients
embrace
life again
Introducing the Prospera™ SCS System with Embrace One™*: Innovation that delivers patient care like no other.
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Keeping therapy optimized remains a challenge
While clinical studies have demonstrated long-term effectiveness of SCS1-5 in the real-world, loss of efficacy and explantation are commonly reported despite the introduction of advanced SCS technology and devices.6-10 Why? Today’s SCS systems can’t quickly diagnose issues that inhibit optimal pain relief. An over-reliance on patients to detect and report issues can cause delays and undermine the effectiveness of SCS therapy. During this time, patients can experience a rapid return of pain and a decline in daily function and quality of life. Without support, the effort required to manage their own therapy often becomes too much.
Prospera SCS System with Embrace One is here to change that.
Prospera SCS System with Embrace One
Image does not reflect the actual appearance or dimensions of the product.
Optimizing the SCS experience daily, and over the lifetime of therapy.
Prospera SCS is paired with Embrace One, a proactive care ecosystem that provides automatic, objective, remote daily monitoring and management of a patient’s device—ensuring that it is optimized today, and over the lifetime of their therapy.
Prospera also features RESONANCE™, the first and only multiphase stimulation paradigm. This combination of technology drives a deeper response into the dorsal horn where pain is processed, targeting the body's own inhibitory pathway and the natural properties of spatial and temporal summative response.11 A preclinical trial has shown that RESONANCE activates a larger and deeper area of response in the dorsal horn than other commercially tested therapies.11
Connected to the needs
of patients and providers
Over the last decade, we've listened to patients and physicians, assessed opportunities for improvement of current SCS capabilities, and developed an individualized approach to change the current paradigm of chronic pain management, with rigorous evaluation through preclinical and clinical work in our landmark BENEFIT studies.
The Prospera SCS System with Embrace One goes beyond device efficacy to truly connect with the day-to-day needs of patients and providers.
BENEFIT-01: Mapping of parameters that influence patient perception and inform unique paresthesia and sub-perception SCS programming.
Benefit-03
A long-term efficacy and safety study of the Prospera SCS System with RESONANCE and automatic, daily transmission of objective device monitoring data with remote programming ongoing in Australia.
Significantly less pain. Functional improvement12
Interim 3-month results:
Percentage of patients with ≥50% overall pain reduction from baseline‡
With mild or no pain (NRS≤3) vs. 0.3 days at baseline
Percentage of patients who reported an improvement in their ability to do everyday tasks and activities§
First-ever clinical validation of SCS proactive care13
Interim 3-month remote management data:
Mean time to address an issueII
Patients who found the process for remote follow-up easy/very easy
Clinicians who reported patients benefited from remote device management
As of this interim analysis, not all participants had completed the 3-month follow-up. Outcomes may change as additional participant data are collected.
Prospera SCS System with Embrace One brings together a deep legacy of excellence, a robust clinical program, and a first-of-its-kind proactive care ecosystem to elevate the SCS experience for everyone.
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References
1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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. 9. 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. 10. BIOTRONIK Neuro data on file. 11. Amirdelfin K, Falowski S, Slee S, et al. Functional ultrasound imaging reveals activation properties of clinical spinal cord stimulation therapy. Poster presented at: North American Neuromodulation Society Annual Conference; January 13, 2023; Las Vegas, NV. 12. Russo M, Yu J, Mohabbati V, et. al. An implantable SCS system with multiphase stimulation and remote device management: Interim 3-month study results. Poster presented at American Society of International Pain Physicians; March 16, 2023; National Harbor, MD. 13. Russo M, Yu J, Mohabbati V, et. al. An implantable SCS system with automated daily remote monitoring and remote programming: First-in-human experience. Poster presented at American Society of International Pain Physicians; March 16, 2023; National Harbor, MD.
Note: 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 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 to the physician's office.
‡Assessed by VAS
§Assessed by Oswestry Disability Index (ODI).
||Confirmed issue addressed via daily monitoring data or when contacting the participant.
NRS=numerical rating scale; ODI=Oswesty Disability Index; QoL=quality of life; SCS=spinal cord stimulation; VAS=visual analog scale.
Brief Summary: Please reference the appropriate product Instructions for Use (IFU) for more information regarding indications, contraindications, warnings, precautions, and potential adverse events. Indications for Use: The Prospera™ Spinal Cord Stimulation (SCS) System is indicated as an aid in the management of chronic, intractable pain in the trunk and/or limbs, which may include unilateral or bilateral pain. Contraindications: Implantation of a spinal cord stimulator may be contraindicated in patients who are unable to operate the SCS system, or who have failed to receive effective pain relief during SCS trial stimulation, or who are poor candidates for surgery. Note that the safety and effectiveness of Prospera SCS system has not been established in pediatric patients or pregnant or nursing patients. Warnings: The following may cause electromagnetic interference, adverse interactions, insufficient or excessive stimulation, damage and function loss of the system, and/or therapy failure: external defibrillation, transcutaneous electrical nerve stimulation (TENs), lithotripsy, RF ablation, hyperbaric oxygen therapy, electrocautery, diathermy therapy (including shortwave, microwave, and therapeutic ultrasound therapies), high-power ultrasound, radiation therapy, Magnetic Resonance Imaging (MRI) scan (refer to Prospera SCS System MRI Guidelines for the system’s MR conditional information), use of portable RF communication equipment near the SCS system, use of a non-BIOTRONIK-provided charger. The Prospera SCS System may interfere with the operation of implanted pacemakers or ICDs. The effects of an implanted Prospera SCS System on other neurostimulators are unknown. Precautions: Device malfunction, loss of therapy, and other adverse events including patient injury may occur if the device is not handled or operated properly as described in the IFU. Refer to the product IFU for comprehensive safety messages when handling the device. Potential Adverse Events: Risks associated with SCS system placement: pain at the implant site, infection, cerebrospinal fluid (CSF) leakage, CSF fistula, epidural hemorrhage, bacterial meningitis, seroma, hematoma, paralysis. Additional risks associated with SCS system use: lead migration; stimulator migration; allergic response or tissue reaction to the implanted system material; skin erosion; radicular chest wall stimulation; disturbed urination; dysesthesia; decubitus; premature battery depletion; and uncomfortable stimulation or ineffective pain management. Furthermore, there is the risk that the SCS therapy may not be effective in relieving symptoms or may cause worsening of symptoms. Refer to the product IFU for a comprehensive list of potential adverse events.
This product is only approved and available for use in the United States.
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