Boston Scientific Receives FDA Approval for Spinal Cord Stimulator System

Boston Scientific Corporation has 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. Boston Scientific is introducing the system at the 8th World Congress of the World Institute of Pain in New York City on May 20-23, 2016.
 
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.
 
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. In addition to the new Precision Montage MRI SCS System, the portfolio includes the Precision Spectra System, which is designed to provide broad coverage for pain with 32 contacts, and the Precision Novi System, the smallest high-capacity non-rechargeable device. The LUMINA clinical study has demonstrated 70 percent greater low-back pain relief with the SCS system in the Illumina 3D family, which was maintained out to 24-months.¹
 
“The Boston Scientific Illumina 3D portfolio allows me to tailor therapy for each patient consistently and effectively,” said Salim Hayek, M.D., Ph.D., program director, Anesthesiology Pain Medicine, University Hospital Case Medical Center, Cleveland, Ohio. “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.”
 
“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,” said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. “This important advancement underscores our commitment to meet the individual needs of chronic pain patients.”
 

 
¹Boston Scientific LUMINA data presented at the 19th annual meeting of the North American Neuromodulation Society