The regulatory nod marks the launch of the Lake Oswego, Oregon-based company’s new Biotronik Neuro business segment.
Propsera features Resonance, a multiphase stimulation paradigm. It pairs with Embrace One, a patient-centric care model that provides automatic, objective, daily remote monitoring, plus management and support. The comprehensive platform combines to treat chronic pain by delivering low levels of electricity to the spinal cord.
Biotronik evaluated its Prospera solution through pre-clinical and clinical work in the BENEFIT studies. BENEFIT-03, a prospective, multicenter, single-arm study is ongoing in Australia. It evaluates the safety and effectiveness of Prospera for treating chronic, intractable pain of the trunk and limbs. Biotronik expects it to yield important insights into the remote patient management and proactive care aspect of SCS therapy.
Dr. Marc Russo, principal investigator, said automatic monitoring and remote programming “will redefine therapy in the SCS space.” Russo also serves as director of Hunter Pain Specialists, Hamilton Day Surgery and Genesis Research Services.
“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 Biotronic Neuro 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.”