Biotronik has gained U.S. Food and Drug Administration (FDA) approval for its Prospera spinal cord stimulation (SCS) system featuring its proprietary Resonance multiphase stimulation paradigm.
 
The paradigms is paired with Embrace One, a patient-centric care model with automatic, objective, daily remote monitoring, management, and support. The approval signals the launch of the company’s new Biotronik Neuro business segment.
 
Prospera was evaluated through preclinical 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,” Dr. Marc Russo, Director of Hunter Pain Specialists, Hamilton Day Surgery and Genesis Research Services and Principal Investigator of the BENEFIT-03 Study, told the press. “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.”
 
The Australian BENEFIT-03 study is evaluating Prospera to treat chronic, intractable trunk and limb pain. Biotronik expects the study to generate useful insights about the impacts of remote patient management and proactive care to optimize the SCS experience.
 
“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.”