embrace
life again

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 with the physician’s office. 
^†BioVantage is an optional subscription service. Reimbursement-related information provided by BIOTRONIK Neuro is obtained from third-party sources. This information is provided for the convenience of the healthcare provider only and does not constitute reimbursement, legal, or compliance advice. Billing and coding information is subject to frequent and unexpected change, therefore, BIOTRONIK Neuro recommends that users refer to the information sources listed to verify accuracy prior to acting on the information provided herein. BIOTRONIK Neuro makes no representation or warranty regarding this information or its accuracy, completeness, or applicability, and assumes no responsibility for updating this information. BIOTRONIK Neuro specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on information on this website. BIOTRONIK Neuro strongly encourages healthcare providers to submit accurate and appropriate claims for services and recommends that you consult directly with payers (eg, the Centers for Medicare & Medicaid Services [CMS]), certified reimbursement coding professionals, other reimbursement experts, and/or legal counsel regarding all coding, coverage, and payment issues.
^‡As shown in preclinical and computational models.


ICD=implantable cardioverter-defibrillator; MRI=magnetic resonance imaging; RF=radiofrequency.

References

1. BIOTRONIK Neuro data on file. 2. Riahi P, Slee S, Kibler A, Muessig D, Stotts L. Computational model-based evaluation of novel multi-phase neuromodulation. Neuromod. 2020;23:e1-e325. 3. Russo M, Yu J, Mohabbati V, Amirdelfan K, Kapural L, Verrils P. Long-term study of SCS system with multiphase stimulation and remote device management: interim 12-month results. Poster presented at: North American Neuromodulation Society Annual Conference; January 18, 2024; Las Vegas, NV.  
 

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.