FDA Approves MRI Spinal Cord Stimulator from Boston Scientific

Boston Scientific announced the launch of the Precision Montage MRI Spinal Cord Stimulator (SCS) System after receiving approval from the U.S. Food and Drug Administration. The Precision Montage System offers customized relief to patients with chronic pain while also enabling safe access to full body magnetic resonance imaging (MRI) in a 1.5 Tesla environment when conditions of use are met.

More than 100 million Americans suffer from chronic pain, which can have a devastating impact on quality of life. Patients with pain sometimes experience a fluctuation in location, type and intensity of pain throughout the day or over time. The Precision Montage MRI SCS System allows patients to undergo a full-body MRI while benefiting from the pain relief of MultiWave Technology. MultiWave Technology enables delivery of multiple waveforms, including burst and higher rates, intended to help respond to changes in pain over time. In an analysis of registry information from 800 patients, it was determined that 72 percent used multiple waveforms to customize their therapy and optimize pain relief.

A press release can be found from Boston Scientific website by following this link.