FDA approval of new leads for Boston Scientific Precision Plus Spinal Cord Stimulator System

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Boston Scientific Corporation today announced US Food and Drug Administration approval of two spinal cord stimulation (SCS) leads for use with its Precision Plus Spinal Cord Stimulator System, the world’s first rechargeable SCS device for the management of chronic pain of the trunk and/or limbs.

SCS leads are designed to deliver electrical pulses from an implantable pulse generator to the spinal cord to mask pain signals to the brain. The new linear 3-4 and 3-6 percutaneous leads, in combination with the recently launched W4 and D4 lead splitters, provide the broadest range of percutaneous lead configurations in the industry, offering wider contact spacing to expand the lead choices available to physicians.


“I have had great results using Boston Scientific’s linear lead with tight contact spacing for my chronic pain patients,” said Stephen Pyles, from the Florida Pain Clinic in Ocala, Florida. “When I want wider contact spacing, these new leads provide that option.”

 

The company plans to launch the products immediately in the US; they were launched in Europe and other international markets earlier this year.

“Our products are designed to meet the unique clinical demands of SCS pain patients,” said Michael Onuscheck, president of Boston Scientific’s Neuromodulation Division. “The approval of these products expands our portfolio of leads for the Precision Plus System, offering pain management physicians more choices to help optimise pain relief for their patients.”


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