FDA approves spinal cord stimulation system for chronic pain

The FDA has approved Prospera, a spinal cord stimulation system to treat those with chronic intractable pain in the upper body and limbs.

According to a press release from Biotronik, the system pairs novel multiphase stimulation with a patient-centric care model that offers automatic, objective, daily remote monitoring as well as continuous support, thereby reducing patient’s reliance on in-person adjustments and reducing the burden on patients and health care providers. The approval marks the launch of the company’s new business segment, Biotronik Neuro.

“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,” Todd Langevin, the company’s president, stated in the release. “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 safety and efficacy of Prospera is currently being tested in BENEFIT-03, a prospective, multicenter, single-arm study in Australia.

“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,” Marc Russo, MBBS, director of Hunter Pain Specialists, Hamilton Day Surgery and Genesis Research Services and principal investigator of the BENEFIT-03 study, said in the release.