Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 15,112.19 -206.04 -1.35%
S&P 500 1,628.93 -22.88 -1.39%
NASDAQ 3,443.20 -38.98 -1.12%
Ticker Volume Price Price Delta
STOXX 50 2,683.98 -16.95 -0.63%
FTSE 100 6,348.82 -25.39 -0.40%
DAX 8,197.08 -32.43 -0.39%
Ticker Volume Price Price Delta
NIKKEI 13,245.22 237.94 1.83%
TOPIX 1,106.57 20.17 1.86%
HANG SENG 20,986.89 -238.99 -1.13%

PRECISION™ PLUS SPINAL CORD STIMULATOR System Receives CE Mark Approval as MRI Conditional



PRECISION™ PLUS SPINAL CORD STIMULATOR System Receives CE Mark Approval as MRI
                                 Conditional

  PR Newswire

  PARIS, August 28, 2012

PARIS, August 28, 2012 /PRNewswire/ --

Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for
use of its PRECISION™ PLUS SPINAL CORD STIMULATOR (SCS) System in patients
with the system and are in need for magnetic resonance imaging (MRI) head-only
scans.  The PRECISION PLUS SCS System is the world's first rechargeable SCS
device.  This approval provides physicians with an additional diagnostic
option for patients with chronic intractable pain.

"As spinal cord stimulation becomes more widespread for control of severe
disabling refractory pain, it is great to know that -- should the need arise
-- head-only MRI scans can be safely performed in patients with the PRECISION
PLUS SCS System," said Dr. Simon Thomson FFPMRCA, consultant in pain medicine
and neuromodulation at Basildon and Thurrock University Hospitals in the
United Kingdom.

Chronic intractable pain is continuous pain that has lasted more than six
months.  Living in constant pain for an extended period of time can have a
devastating impact on quality of life for many patients.  Without relief, or
the hope for relief, many patients lose the ability to sleep, work, and
function normally.  Chronic pain affects one in five adults in Europe, or
about 95 million people 15 to 64 years of age.

"We are pleased to announce that patients implanted with the PRECISION PLUS
SCS System will now be able to undergo MRI head scans," said Michael
Onuscheck, senior vice president and president of Europe, Middle East and
Africa at Boston Scientific. "We understand the need to provide physicians the
necessary options to be able to manage their patients' care and believe this
new MRI labeling will play a role for them."

Spinal cord stimulation is a reversible therapy that manages pain through an
implantable pulse generator (IPG) and thin wires called electrodes, or
"leads," that are implanted in the spinal column.  The device electrically
stimulates specific nerves of the spinal cord to mask the brain's perception
of specific pain signals that move up the spinal cord.  To date, about 350,000
patients with chronic pain have been treated worldwide with SCS therapy.

About the PRECISION™ PLUS SCS System

The PRECISION PLUS SCS System was approved in the United States in 2004 and
received approval in Europe and Canada in 2005.  The system is the world's
first rechargeable IPG.  Today, more than 60,000 patients worldwide have been
treated using this system.  When compared to non-rechargeable SCS systems,
rechargeable SCS systems may offer clinical benefits by extending therapeutic
longevity and therefore avoiding frequent replacement surgeries and
complications that may arise from repeated surgeries.

All cited trademarks are the property of their respective owners.  Caution:
The law restricts these devices to sale by or on the order of a physician.
 Inactions, contraindications, warnings, and instructions for use can be found
on the product labeling supplied with each device.  Information is for use
only in countries with applicable health authority product registrations.  

About Boston Scientific Neuromodulation

Boston Scientific Neuromodulation is an innovation leader in implantable pain
management technology.  Through its investments in technology, clinical
science, and world-class service, Boston Scientific Neuromodulation is
committed to making life smoother for physicians and patients.  For more
information on PRECISION PLUS SCS System 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 markets for our products, new product indications, 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.

Contact: CONTACT: Simonetta Balbi, +393387936422 (mobile), Media Relations
EMEA, Boston Scientific Corporation, Simonetta.balbi@bsci.com ; Steven
Campanini, +1-508-652-5740 (office), Media Relations, Boston Scientific
Corporation, steven.campanini@bsci.com ; Michael Campbell, +1-508-650-8023
(office), Investor Relations, Boston Scientific Corporation,
investor_relations@bsci.com
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement