Boston Scientific gets FDA OK for spinal device

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Boston Scientific Corp. (NYSE:BSX) was granted U.S. Food & Drug Administration approval for leads designed for use in its Precision Plus spinal cord stimulator system.

The Linear 3-4 and Linear 3-6 leads, when combined with the recently approved W4 and D4 lead splitters, provide physicians with the broadest range of percutaneous lead configurations in the industry, according to the company.

The new leads offer wider contact spacing, the Natick, Mass.-based medical device giant said.

Boston Scientific‘s spinal cord stimulator system is designed to deliver electrical pulses that mask back pain signals on their way to the brain.

BSX launched its two new lead splitters, designed to enable multi-site placement of up to four leads, in June.

The company designed its Precision Plus system to pass electrical signals along the spinal cord to the brain, masking pain signals by fooling the brain into perceiving them as pleasurable. The device is aimed at patients with chronic pain in the torso or limbs who haven’t had any luck treating the symptoms with physical therapy, drugs or surgery. BSX, which acquired the technology in the 2004 acquisition Advanced Bionics Corp., adapted the system from its work with cochlear implant technology , according to a Frost & Sullivan report analyzing the neurostimulation market.

That market is expected to grow by more than 204 percent by 2013, according to the report, with the spinal cord stimulation segment accounting for the lion’s share. SCS technologies grabbed about 70 percent of total neurostimulation product sales in 2006, according to Frost & Sullivan.

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MassDevice Staff

By MassDevice Staff

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
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