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Boston Scientific Announces FDA Approval Of New Leads For The Precision Plus™ Spinal Cord Stimulator System

Boston Scientific Corporation (NYSE: BSX) announced U.S. 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. The Linear™ 3-4 and Linear™ 3-6 Percutaneous Leads
offer wider contact spacing to expand the lead choices available to
physicians. The Company plans to launch the products immediately in the
U.S.; they were launched in Europe and other international markets
earlier this year.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 leads, in combination with the recently launched W4 and D4 lead
splitters, provide the broadest range of percutaneous lead
configurations in the industry.


"I have had great results using Boston Scientific's Linear Lead with
tight contact spacing for my chronic pain patients," said Stephen Pyles,
M.D., of the Florida Pain Clinic in Ocala, Florida. "When I want wider
contact spacing, these new leads provide that option."


"Our products are designed to meet the unique clinical demands of SCS
pain patients," said Michael Onuscheck, Senior Vice President and
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 optimize pain relief for their patients."


Pain is the most common reason Americans seek medical treatment, and
many chronic pain patients have found that SCS helps them manage their
pain and live better lives.


About Boston Scientific Neuromodulation


Boston Scientific Neuromodulation is an innovation leader in implantable
pain management technology. The Precision Plus™ Spinal Cord Stimulator
System, powered by SmoothWave™ Technology, uses pulses of electricity
delivered directly along nerve fibers through the spinal cord to mask
pain signals to the brain. Through its investments in technology,
clinical science and world-class service, Boston Scientific
Neuromodulation is committed to Making life smoother™ for physicians and
patients.


Cautionary Statement Regarding Forward-Looking Statements


This press release contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements may be identified by words like "anticipate,"
"expect," "project," "believe," "plan," "estimate," "intend" and
similar words. These forward-looking statements are based on our
beliefs, assumptions and estimates using information available to us at
the time and are not intended to be guarantees of future events or
performance. These forward-looking statements include, among other
things, statements regarding new product launches and launch cadence,
regulatory approvals, clinical trials, product performance and
competitive offerings. If our underlying assumptions turn out to be
incorrect, or if certain risks or uncertainties materialize, actual
results could vary materially from the expectations and projections
expressed or implied by our forward-looking statements. These factors,
in some cases, have affected and in the future (together with other
factors) could affect our ability to implement our business strategy and
may cause actual results to differ materially from those contemplated
by the statements expressed in this press release. As a result, readers
are cautioned not to place undue reliance on any of our forward-looking
statements.Factors that may cause such differences include, among other things:
future economic, competitive, reimbursement and regulatory conditions;
new product introductions; demographic trends; intellectual property;
litigation; financial market conditions; and, future business decisions
made by us and our competitors. All of these factors are difficult or
impossible to predict accurately and many of them are beyond our
control. For a further list and description of these and other
important risks and uncertainties that may affect our future operations,
see Part I, Item 1A Risk Factors in our most recent Annual
Report on Form 10-K filed with the Securities and Exchange Commission,
which we may update in Part II, Item 1A Risk Factors in Quarterly
Reports on Form 10-Q we have filed or will file hereafter. We disclaim
any intention or obligation to publicly update or revise any
forward-looking statements to reflect any change in our expectations or
in events, conditions, or circumstances on which those expectations may
be based, or that may affect the likelihood that actual results will
differ from those contained in the forward-looking statements. This
cautionary statement is applicable to all forward-looking statements
contained in this document.

Source:http://www.medicalnewstoday.com/articles/196290.php