London, UK (May 23, 2011) – Boston Scientific Corporation (NYSE: BSX) today announced CE Mark approval of the Clik™ Anchor for its Precision Plus™ 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 22 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(1) and 38 percent of patients with chronic pain report that their pain is not adequately managed(2). 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™ 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(3). 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: www.bostonscientific.com.
1. 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.
2. Pain in Europe – A report – NFO WorldGroup Market Research 2003
3. Cameron T. Safety and Efficacy of Spinal Cord Stimulation for the Treatment of Chronic Pain: a 20-year Review. J Neurosurg Spine 2004; 100: 254-267.
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 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.
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Head of Communication
Boston Scientific EMEA
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