Medical device maker Medtronic announced in a press statement Monday that it has begun a clinical trial testing neurostimulation therapy of its Specify 5-6-5 spinal cord stimulation treatment. The first-of-its-kind trial will evaluate the company's therapy for patients suffering from failed back surgery syndrome (FBSS) and predominant low back pain.
The company's study, dubbed PROMISE, will evaluate up to 300 patients from across the globe. Medtronic estimates around 10% of the entire U.S. population lives with back pain; the company further projects that 20% of European adults also suffer from chronic pain. The company's neurostimulation therapy has treated more than 250,000 people so far, according to Medtronic.
PROMISE's principal investigator, Dr. Phillipe Rigoard, said in the release:
Spinal cord stimulation has become an increasingly valued treatment approach in chronic pain, and we look forward to participating in the latest study... If the PROMISE results are positive, they will provide critically needed relief for those patients suffering from chronic low back pain associated with FBSS.
Medtronic is looking for a 50% reduction in reported pain from study patients following the beginning of therapy.
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