FDA Approval for BIOTRONIK’s Prospera™ Spinal Cord Stimulation System
Global Leader in Cardiac Rhythm Technology Solutions Expands Therapies for the Treatment of Chronic Intractable Pain with a New Approach to Managing Spinal Cord Stimulation
The company today announced U.S. Food and Drug Administration (FDA) approval for Prospera™, a spinal cord stimulation (SCS) system. The system features RESONANCE™, the first and only multiphase stimulation paradigm, paired with Embrace One™, a patient-centric care model that makes proactive care possible by offering automatic, objective, daily remote monitoring and ongoing management and support.1 This approval marks the launch of the company’s new business segment, BIOTRONIK Neuro.
Millions of people all over the world suffer from chronic intractable pain, a severe, constant, and debilitating pain that is not curable and cannot be relieved by ordinary medical or pharmaceutical measures. Spinal cord stimulation can provide these patients relief by stimulating the spinal cord with low levels of electricity.
Most SCS patients require periodic adjustments and ongoing compliance to ensure their therapy remains optimized for adequate treatment. Currently available technologies require patients to wait for those adjustments in person, often for prolonged periods of time, without optimized therapy. This can lead to rapid return of pain, increased difficulty managing pain, decreased quality of life, together with a higher chance of therapy abandonment.2,3 BIOTRONIK Neuro aims to improve patient care while reducing the burden on clinicians, caregivers, and patients.
BIOTRONIK Neuro’s innovative solution has been evaluated through pre-clinical and clinical work in the BENEFIT studies. “BIOTRONIK’s remote technologies are moving the industry forward. Allowing patient devices to be automatically monitored and remotely programmed seven days a week will redefine therapy in the SCS space,” said Dr. Marc Russo, Director of Hunter Pain Specialists, Hamilton Day Surgery and Genesis Research Services and Principal Investigator of the BENEFIT-03 Study. “In the coming years, I anticipate a shift in the industry toward increased use of these technologies following the path BIOTRONIK has set, which will provide real benefits to patients and the clinical community.”
BENEFIT-03 is a prospective, multi-center, single-arm study ongoing in Australia to evaluate the safety and effectiveness of Prospera for the treatment of chronic intractable pain of the trunk and limbs. This study is expected to yield important insights regarding the impacts of implementation of remote patient management and proactive care to ensure the SCS experience is optimized daily and over the lifetime of the therapy.
“BIOTRONIK pioneered the ability to monitor patients remotely in cardiac rhythm management, enabling early detection and treatment of critical events. With the introduction of a truly proactive patient-centric care ecosystem, BIOTRONIK Neuro has built upon this technology,” said BIOTRONIK Neuro’s President Todd Langevin. "We believe that providing patients a new level of service that identifies issues quickly and allows for the ability to intervene appropriately will have a meaningful impact on their day-to-day lives and ultimately long-term therapy success.”
1Embrace 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.
2Amirdelfan K., et al. Health-related and economic impacts of clinic visit burdens for spinal cord stimulation patients and caregivers. Poster presented at: North American Neuromodulation Society Annual Meeting; January 12-15, 2023; Las Vegas, NV.
3Amirdelfan K., et al. Rapid return of pain upon discontinuation of commercial spinal cord stimulation systems in patients with chronic pain. Poster presented at: American Society of Pain and Neuroscience Annual Conference; July 14-17, 2022; Miami Beach, FL.
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.
Prospera SCS System is approved in the US only and is not available outside of the US.
At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases as well as chronic pain. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular, endovascular and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.