Prospera™ Spinal Cord Stimulation System with Embrace One™
The Prospera Spinal Cord Stimulation (SCS) System with Embrace One* is enhancing the SCS experience with a first-of-its-kind approach: one that’s not just implanted, but truly connected to the needs of patients and providers. Through automatic, objective, daily remote monitoring of the device and therapy, we put true proactive care† into action to ensure the therapy you prescribe remains optimized for each patient, every day, over the lifetime of the therapy.
Keeping therapy optimized with conventional SCS systems can be 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 technology6-9. Simple device issues often go undetected for far too long, which can negatively impact patients in a number of ways.
The Prospera SCS System with Embrace One offers patient care like no other
Prospera SCS System
MRI for Real Life
RESONANCE™ Technology
Embrace One
Clinical Evidence
Delivering an optimal SCS experience
The first and only SCS system that features:
- RESONANCE, the only multiphase stimulation paradigm available
- Embrace One, a truly first-of-its-kind, proactive care model made possible only through automatic, objective, remote daily monitoring
All images are rendered.
MRI for real life: More access with fewer restrictions
For the 84% of patients with SCS who will need at least 1 MRI within 5 years of implant3, BIOTRONIK Neuro has them covered.
First and only SCS system that allows 1.5T & 3T full body scanning in
normal operating mode with no exclusion zones
A network of MRI partners across 500+ facility locations2
Pre- and post-MRI device checks that can be conducted remotely
An evolution in therapeutic stimulation
RESONANCE powered by BioARC uses a proprietary pattern of stimulation to activate the dorsal horn where pain is processed.
- Delivers a sequence of micropulses with each unit of stimulation
- Stimulates and charge balances simultaneously by rapidly rotating a cathode between up to 4 selected electrodes.
- Achieves up to a 300% increase in pulse density, while reducing the charge of each micropulse2†. This design is intended to eliminate the problem of overstimulation
Watch the video to see how RESONANCE multiphase stimulation works.
Shown to have a substantial effect on dorsal horn structures14§
RESONANCE 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.
BioARC KEEPS PROGRAMMING SIMPLE AND STIMULATION PERSONALIZED
The unique stimulation pattern of BioARC allows you to focus your expertise on patient care rather than on programming.
Embrace One: Connected to what counts
The only proactive care ecosystem that’s truly connected to the needs of patients and providers, before implant and beyond.
PATIENT BENEFITS
The only SCS system with automatic, objective, remote daily monitoring, powered by HomeStream™, our remote monitoring engine which enables the wireless data transmission.
SCS therapy support for patients 7 days a week from dedicated Embrace One Care Team members
Embrace One App offers patients 24/7 access to helpful content and ability to report outcomes
PRACTICE BENEFITS
Drive efficiencies with 24/7 transparency of SCS status and
patient journey
Efficiently submit and track patient authorizations and psychological evaluations
Advanced cybersecurity standards ensure data and therapy settings are transmitted securely
Daily remote monitoring and proactive care are designed to address key unmet needs
- Ensuring early identification of potential issues
- Reducing time to intervention
- Minimizing time spent with non-optimized stimulation
- Helping maintain relief and belief in therapy
Keeping stimulation optimized on a daily basis
HomeStream™ transmits data from the patient's stimulator to a secure cloud, where the data is stored for viewing by BIOTRONIK Neuro and clinicians in the Provider Portal. With automatic, objective, remote daily monitoring, potential issues can be identified before they become a problem. If intervention or patient education is needed, the Embrace One Care Team can do so remotely and proactively.
Overall and daily: Significantly less pain. Functional Improvement.6
Interim 3-month results from a long-term efficacy and safety study (BENEFIT-03) of the Prospera SCS System with RESONANCE and automatic, daily transmission of objective device data monitoring with remote programming. As of this interim analysis not all participants had completed the 3-month follow up. Outcomes may change as additional participant data are collected.
PAIN REDUCTION
IMPROVED FUNCTION
DAILY PAIN AND SLEEP IMPROVEMENTS
First-ever clinical validation of SCS and proactive care5
Interim 3-month results from BENEFIT 03: a long-term efficacy and safety study (ongoing in Australia) of the Prospera SCS System with RESONANCE and automatic, daily transmission of objective device data monitoring with remote programming.
DAILY TRIGGERS
PROACTIVE CARE RESPONSE TIME
PATIENT AND CLINICIAN EXPERIENCE WITH REMOTE DEVICE MANAGEMENT (RDM)
*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 with the physician’s office.
‡As shown in a preclinical model.
§Assessed by patient-reported NRS pain intensity scores collected in the at-home setting via electronic watches or written diaries.
eCAPT=evoke compound action potential threshold; EPG=external pulse generator; HRQoL=health-related quality of life; IPG=internal pulse generator; MRI=magnetic resonance imaging; NRS=numerical rating scale; ODI=Oswestry Disability Index; OOR=out of range; RDM=remote device managment; SCS=spinalcord stimulation; SQ=sleep quality; VAS=visual analogue scale.
References
1. Amirdelfin K, Antony A, Levy R, et al. Patient burdens associated with spinal cord stimulation: impact of wait times to address device-related issues in a real-world cohort with chronic back and leg pain. Poster presented at: World Institute of Pain World Congress; August 24, 2022; Budapest, Hungary. 2. BIOTRONIK Neuro data on file. 3. Desai MJ, Hargens LM, Breitenfeldt MD, et al. The rate of magnetic resonance imaging in patients with spinal cord stimulation. Spine. 2015;40(9):e531-e537 4. 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. 5. Russo M, Yu J, Mohabbati V, Amirdelfan K, Kapural L, Verrils P. 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 16-18, 2023. National Harbor, MD. 6. Russo M, Yu J, Mohabbati V, Amirdelfan K, Kapural L, Verrils P. An implantable SCS system with multiphase stimulation and remote management: interim 3-month study results. Poster presented at: American Society of International Pain Physicians; March 16-18, 2023. National Harbor, MD.
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.