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 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.
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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 introduced cardiac remote monitoring to save time on patient care and improve clinical outcomes. We’re pleased to see this technology taken to the next level in spinal cord stimulation with the first truly proactive, patient-centric care model,” said Dr. Alexander Uhl, Chief Executive Officer, BIOTRONIK. “We’re confident that Prospera with Embrace One will significantly and positively impact patients’ lives as well as improve long term treatment outcomes. This represents an exciting opportunity for BIOTRONIK in a new and growing field.”4
