How Spinal Cord Stimulation Can Help Patients with Chronic Pain

A global company that has been making devices for 60 years and has vast experience helping patients with heart and blood vessel diseases, BIOTRONIK has expanded to the chronic pain space with BIOTRONIK Neuro. With its new spinal cord stimulation (SCS) system Prospera™, BIOTRONIK’s neuromodulation team aims to support chronic pain patients and help them embrace life again. 

But what does this actually mean? We gathered and answered some common questions on chronic pain and treatment options.  

What exactly is chronic intractable pain? 

Chronic intractable pain is a severe, constant, and debilitating pain. It’s unfortunately not curable and can’t always be relieved by common pain management therapies or medications. This condition can come from an injury, disease, or a medical condition and can persist even after what first caused the pain has been treated or healed. Unlike more common chronic pain, intractable pain has a broader impact on the body’s cardiovascular, hormone and nervous systems. 

How many people are affected and how does it influence their lives? 

Chronic pain can have a significant impact for those affected every day. It can limit everything from work and social life to exercise and self-care activities, which can lead to emotional distress, such as depression, anxiety, fatigue, and sleeping issues.  

Worldwide an estimate of 10-20 percent of the population suffers from chronic pain.^1-2 The World Health Organization (WHO) has recognized chronic pain as a major public health issue. This demonstrates the real need for effective management and treatment strategies.

What are current therapy options? 

The path to relief can be really challenging. The best treatment option for chronic pain will vary depending on the individual and what exactly is causing the pain. Current treatment options can include medications, conservative pain management therapies, or interventional therapies like spinal cord stimulation. A combination of treatment options may be necessary to effectively manage chronic pain. 

What is spinal cord stimulation (SCS)? 

SCS is an interventional treatment used to relieve chronic pain. The treatment involves implanting a stimulator with leads near specific nerves in your back that sends electrical impulses to interrupt and mask the pain signals before they reach the brain.  

How is BIOTRONIK Neuro trying to improve current SCS treatment options for patients? 

Effectively treating and managing chronic pain is important for improving the quality of life for those affected. With the introduction of the Prospera System, patients can have the peace of mind that they have access to the most advanced scans if they may need an MRI. Prospera is the only SCS system that allows for full body 1.5T and 3T scans. BIOTRONIK Neuro is also the only company to provide a truly proactive care support system for its patients with its Embrace One™ Care Team.* That means that through automatic, daily remote monitoring, your dedicated Care team is making sure your therapy is working best for you—anytime, anywhere.   

Where can I find more information on BIOTRONIK’s SCS system?  

Visit EmbraceLifeAgain.com to learn more and access a video that provides further information.  

Prospera SCS System is approved in the US only and is not available outside of the US.

 

*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. 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.  

 

Rx Only.  

 

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.