Biotronik announces US FDA approval of Prospera spinal cord stimulation system


Biotronik has announced US Food and Drug Administration (FDA) approval for Prospera—a new spinal cord stimulation (SCS) system. The system features RESONANCE, which the company claims is the first and only multiphase stimulation paradigm, paired with Embrace One, which is a patient-centric care model that makes proactive care possible by offering automatic, objective, daily remote monitoring, and ongoing management and support.

As per a Biotronik press release, this approval marks the launch of the company’s new business segment, Biotronik Neuro.

Most SCS patients require periodic adjustments and ongoing compliance to ensure their therapy remains optimised for adequate pain treatment. Currently available technologies require patients to wait for those adjustments in person, often for prolonged periods of time, without optimised therapy, the release also notes. This can lead to a rapid return of pain, increased difficulty managing pain, decreased quality of life, and ultimately a higher chance of therapy abandonment.

Biotronik Neuro is aiming to improve patient care while reducing the burden on clinicians, caregivers, and patients, the release continues, and its innovative solution has been evaluated through preclinical and clinical work in the BENEFIT studies.

“Biotronik’s remote technologies are moving the industry forward,” said Marc Russo (Hunter Pain Specialists, Newcastle, Australia), principal investigator of the BENEFIT-03 study. “Allowing patient devices to be automatically monitored and remotely programmed seven days a week will redefine therapy in the SCS space. 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, multicentre, 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 optimised daily, and over the lifetime of the therapy, Biotronik’s press release details.

“Biotronik introduced cardiac remote monitoring to save time on patient care and improve clinical outcomes,” said Biotronik CEO Alexander Uhl. “We are pleased to see this technology taken to the next level in spinal cord stimulation with the first truly proactive, patient-centric care model. We are 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.”


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