FDA approves Boston Scientific’s Precision Montage MRI-safe spinal cord stimulator

Boston Scientific (NYSE:BSX) said it won FDA approval for its Precision Montage MRI-safe spinal cord stimulator for chronic pain and plans to launch the device tomorrow.

The Precision Montage MRI SCS is cleared for full-body, 1.5 Tesla MRI scans, the Marlborough, Mass.-based company said. It’s designed to deliver multiple waveforms so patients can tailor their therapy as their pain evolves, and uses Boston Scientific’s IlLumina 3D algorithm to create a computer model so surgeons can target the source of the pain.

“The Precision Montage MRI SCS system is a key addition to our IlLumina 3D portfolio, offering patients more choices to manage and personalize their therapy,” neuromodulation president Maulik Nanavaty said in prepared remarks. “This important advancement underscores our commitment to meet the individual needs of chronic pain patients.”

“The Boston Scientific IlLumina 3D portfolio allows me to tailor therapy for each patient consistently and effectively,” added Dr. Salim Hayek of Cleveland’s University Hospital Case Medical Center. “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.”

Boston Scientific said it plans to launch the Precision Montage MRI at the annual World Institute of Pain congress in New York City this week.

In December, the company released data from the Lumina trial of its Precision Spectra SCS showing a 70% improvement in back pain relief over the previous–generation Precision Plus SCS.

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