Biotronik Announces FDA Approval of Prospera SCS System

by James Cavuoto, editor

April 2023 issue

The market for spinal cord stimulation systems got a little more crowded this month when Biotronik, the German medtech manufacturer, announced FDA approval for its Prospera system. Biotronik is a major player in the cardiac devices market, where it competes with Medtronic, Boston Scientific, and Abbott—three incumbents in the SCS space. The company launched a new business segment called Biotronik Neuro, based in Lake Oswego, OR, to pursue the neuromodulation market.

Prospera incorporates a novel stimulation paradigm called Resonance and a patient-centric care model called Embrace One that offers automatic, objective, daily remote monitoring and ongoing management and support. The company is touting these two features as advantages over existing SCS devices. Currently, most patients require periodic stimulation 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.

The Prospera system 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 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.”

The entry this year of Biotronik Neuro and Saluda Medical, two firms that have stressed the efficiency of neuromodulation therapy, promises to add some uncertainty to the SCS market, which is currently dominated by Medtronic, Boston Scientific, Abbott, and Nevro. Compared to Saluda, Biotronik stands to benefit from its manufacturing capabilities and its long experience in the cardiac device market. Neurotech Reports projects that the worldwide SCS market will be $2.54 billion in 2023.