FDA Approves Boston Scientific PMA for Spinal Cord Stimulator

FDA has approved a Boston Scientific PMA for its Precision Montage MRI Spinal Cord Stimulator (SCS) System which is intended to help relieve chronic pain while also enabling safe access to full body magnetic resonance imaging in a 1.5 Tesla environment. The device uses the company’s MultiWave technology to deliver multiple waveforms, including burst and higher rates, that helps patients respond to changes in pain over time, according to the company. “In an analysis of registry information from 800 patients, it was determined that 72% used multiple waveforms to customize their therapy and optimize pain relief,” it says. “The new SCS system also expands the suite of Boston Scientific products that leverage the Illumina 3D algorithm, a three-dimensional anatomy-driven computer model designed for simple point-and-click pain targeting to support physicians in treating chronic pain.”