Saluda Medical Pty. Ltd., of Artarmon, Australia, made waves in 2019, winning the CE mark for its Evoke closed-loop spinal cord stimulation (SCS) system. The good news kept coming following the publication of results from a pivotal study in The Lancet Neurology.
Spinal cord stimulation to treat pain has long been associated with mixed efficacy and substantial side effects such as paresthesia, which is an unpleasant tingly or prickly sensation. Redwood City, Calif.-based Nevro Corp. famously has built a multi-billion-dollar business on next-gen, pain neurostimulation technology that improves efficacy and reduces side effects. Sommerville, Mass.-based Micro-leads Medical Inc. hopes that it could be next in successfully further refining spinal cord stimulation.
The U.S. FDA has approved the Senza Omnia Spinal Cord Stimulation (SCS) system from Redwood City, Calif.-based Nevro Corp. The system is the first such system that delivers Nevro's high frequency 10,000 Hz stimulation, known as HF10, but also all other therapeutic spinal cord stimulation frequencies.
