FDA Approves Innovative Spinal Cord Stimulator for Full-Body MRI Scanning

Patients that suffer from chronic pain now have the option to use a new spinal cord stimulator, and still be able to undergo full-body Magnetic Resonance Imaging (MRI) exams.

Chronic pain affects some 1.5 billion people around the world including 100 million Americans, and 95 million Europeans, and costs the European healthcare systems alone EUR 300 billion every year. Inaccessibility to MRI scans is a barrier preventing such patients from benefitting from SCS therapy.

Boston Scientific (Marlborough, MA) received US Food and Drug Administration (FDA) approval for the new Precision Montage MRI Spinal Cord Stimulator (SCS) System. The system provides customized relief for chronic pain, while at the same enabling patients’ safe access to full-body 1.5-Tesla MRI scans, when conditions of use are met. Boston Scientific launched the system in May 2016.

The Precision Montage MRI SCS system uses MultiWave technology and can deliver pain relief throughout the day in multiple waveforms, in multiple locations, and with fluctuating intensity and type. The SCS system also uses the Illumina 3D algorithm, a 3D computer model that helps clinicians target and treating chronic pain. A survey of 800 patients showed that 72% used multiple waveforms to customize and optimize their therapy, and pain relief.

Salim Hayek, MD at the University Hospital, Cleveland, Ohio, said, "The Boston Scientific Illumina 3D portfolio allows me to tailor therapy for each patient consistently and effectively. With the approval of the Precision Montage MRI SCS System, more of my patients can benefit from this powerful technology since they can now have access to future MRI scan needs."

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