• 03.02.2012, 08:05:03
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  • OTE0003

Boston Scientific Announces CE Mark Approval and European Launch for New Infinion? 16 Percutaneous Lead for Precision Plus? Spinal Cord Stimulator System

Paris and Miami Beach, Florida (ots/PRNewswire) -

Boston Scientific Corporation announces CE Mark approval of the
Infinion(TM) 16 Percutaneous Lead for its Precision Plus(TM) Spinal
Cord Stimulator (SCS) System, the first rechargeable SCS device for
chronic pain management. The first patient implant in Europe using
the Infinion(TM) 16 Lead was performed by Kliment Gatzinsky, M.D.,
Ph.D., and David Revesz, M.D., of the Neurosurgery Department atthe
Sahlgrenska University Hospital in Guldheden, Sweden.

The Infinion 16 Lead is the world's first and only 16-contact
percutaneous lead and the latest innovation in Boston Scientific's
comprehensive percutaneous lead portfolio. The Company announced the
approvaltoday at the World Institute of Pain (WIP) Congress, which
runs from February 4 - 6 in Miami Beach. The Infinion 16 Lead is
currently commercially available in the U.S. and will be introduced
in CE Mark countries immediately.

SCS leads are designed to deliver electrical pulses from an
implantable pulse generator to the spinal cord to mask pain signals
to the brain (known as paresthesia). Until now, percutaneous leads
have offered a maximum of eight stimulating contacts. By providing
twice the number of contacts than any previous percutaneous lead, the
Infinion 16 Lead is designed to offer more coverage of the spinal
cord for the management of chronic pain.

"I appreciate that for the first time, it is possible to place 16
contacts with a single percutaneous lead using a small insertion
needle," said Dr. Gatzinsky. "This lead will provide me with more
options to optimize the paresthesiacoverage to bring relief for
chronic pain patients." Dr. Revesz added, "The Infinion 16 Lead is
very responsive, with excellent steering that allows easy placement
in the target area."

Chronic pain is a debilitating condition that affects
approximately 138 million people in Europe or more than one in five
adults.[1] Tens of thousands of patients with chronic pain have found
that SCS systems help them manage their pain. SCS is a reversible
therapy that manages pain through an implantable pulse generator and
external devices that control therapy and charge theimplant.

"The Infinion 16 Lead is the latest advance in SCS lead technology
and an exciting addition to our unrivaled percutaneous lead
portfolio," stated Maulik Nanavaty, Senior Vice President and
President of the Boston Scientific Neuromodulation Division. "We
believe that the European launch of the Infinion 16 Lead, coupled
with increased awareness of pain management treatment alternatives,
will allow us reach a wider patient population. Boston Scientific
continues its commitment to innovation by offering pain management
physicians more choices to help optimize pain relief for their
patients."

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 investments in
technology, clinical science, and world-class service, Boston
Scientific Neuromodulation is committed to Making life smoother(TM)
for physicians and patients. For more information on Precision Plus
technology, visit:http://www.ControlYourPain.com.

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and
marketer of medical devices that are used in a broad range of
interventional medical specialties. For more information, please
visit: http://www.bostonscientific.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and 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, future innovation,
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.

1. United Nations World Population Monitoring 2001. United Nations
Publication, 2001;1-80.

Rückfragehinweis:
Simonetta Balbi, PR and Corporate Communication EMEA,
Boston Scientific, Mobile +39-3387936422, Office +39-02-269831

OTS-ORIGINALTEXT PRESSEAUSSENDUNG UNTER AUSSCHLIESSLICHER INHALTLICHER VERANTWORTUNG DES AUSSENDERS - WWW.OTS.AT | PRN

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