Boston Scientific Receives CE Mark Approval of New Clik(TM) Anchor for Precision Plus(TM) Spinal Cord Stimulator SystemBy Boston Scientific Corporation, PRNE
Sunday, May 22, 2011
LONDON, May 23, 2011 -
- New Technology Designed to Improve Lead Anchoring for Physicians to
be Introduced at INS World Congress
Boston Scientific Corporation (NYSE: BSX) today announced CE
Mark approval of the Clik(TM) Anchor for its Precision Plus(TM) Spinal Cord
Stimulator (SCS) System, the world's first rechargeable SCS device for
chronic pain management. The Clik Anchor features an innovative locking
system designed to improve lead anchoring and consistency. Locking into place
on the lead with a simple turn of a hex wrench, the new anchor provides
tactile and audible confirmation for physicians that the lead is secured. The
Company is introducing the Clik Anchor at the International Neuromodulation
Society (INS) World Congress May 21 to 26 in London, UK.
Kliment Gatzinsky, M.D., of Sahlgrenska University Hospital in
Göteborg, Sweden, and the first physician in Europe to evaluate the Clik
Anchor operatively, said "The Clik Anchor is easy to use. I appreciate its
separate locking mechanism using the hex wrench, in addition to fixating
sutures designed to improve lead anchoring and stability."
Chronic pain affects one in five adults in Europe and 38
percent of patients with chronic pain report that their pain is not
adequately managed. Spinal cord stimulation (SCS) is a clinically proven
and cost-effective option for chronic neuropathic pain patients who have
failed conventional medical management. It is a reversible therapy that
manages pain through an implantable pulse generator and external devices that
control therapy and charge an implant. Tens of thousands of patients with
chronic pain have found that SCS helps manage their pain.
Boston Scientific's Precision Plus SCS System is indicated as
an aid in management of chronic intractable pain. It is powered by
SmoothWave(TM) Technology, which masks pain signals by delivering
independently controlled pulses of electricity through SCS leads. In a
20-year retrospective analysis of published SCS studies, lead migration was
cited as the primary complication in SCS procedures. Anchors are designed
to secure leads and minimize unwanted migration.
"With European approval and launch of the Clik Anchor, we have
added six new products to our Neuromodulation portfolio in the past year,"
said Michael Onuscheck, Senior Vice President and President of Boston
Scientific's Neuromodulation Division. "The Clik Anchor complements our SCS
leads portfolio, which gives physicians the most comprehensive array of
percutaneous lead options in the market."
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and
marketer of medical devices whose products are used in a broad range of
interventional medical specialties. For more information, please visit:
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 launches and launch cadence, regulatory approvals, clinical trials,
product performance, our SCS lead portfolio 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
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things: future economic, competitive, reimbursement and regulatory
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uncertainties that may affect our future operations, see Part I, Item 1A -
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This cautionary statement is applicable to all forward-looking statements
contained in this document.
 Breivik H, Collet B, Ventafridda V, Cohen R, Gallacher D. Survey of
chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur
J Pain 2006;10:287-333.
 Pain in Europe - A report - NFO WorldGroup Market Research 2003
 Cameron T. Safety and Efficacy of Spinal Cord Stimulation for the
Treatment of Chronic Pain: a 20-year Review. J Neurosurg Spine 2004; 100:
CONTACT: Géraldine Varoqui Head of Communication Boston Scientific EMEA +49-2102-489-461 email@example.com
Tags: Boston Scientific Corporation, London, May 23, United Kingdom