Healthcare Industry News: Spinal Cord Stimulator
News Release - March 24, 2011
Boston Scientific Receives FDA Approval of New Clik(TM) Anchor for Precision Plus(TM) Spinal Cord Stimulator SystemNew technology designed to improve lead anchoring speed and consistency for physicians
NATICK, Mass., March 24, 2011 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (NYSE:BSX ) today announced U.S. Food and Drug Administration (FDA) approval and U.S. launch 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 speed and consistency. Locking into place on the lead with a simple turn of a hex wrench, it provides tactile and audible confirmation for physicians that the lead is secured. The Company is introducing the Clik Anchor at the American Academy of Pain Medicine Annual Meeting, which begins today in Washington, D.C.
"The Clik Anchor is easy to use and gives me confidence that the lead is secure," said Salim Hayek, M.D., Ph.D., of the University Hospitals Case Medical Center in Cleveland, Ohio. "This new product will benefit my patients and my practice with simpler, more consistent lead anchoring."
According to the National Center for Health Statistics, pain is the most common reason Americans seek medical treatment, and an estimated 26 million Americans experience frequent back pain. Tens of thousands of patients with chronic pain have found that SCS systems help them manage their pain. Spinal Cord Stimulation is a reversible therapy that manages pain through an implantable pulse generator and external devices that control therapy and charge an implant.
Boston Scientific's Precision Plus SCS System, powered by SmoothWave™ Technology, masks pain signals by delivering independently controlled pulses of electricity through SCS leads. Anchors are designed to secure leads and minimize unwanted migration.
"With 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, a leader in microelectronic implantable technologies used to treat chronic neuropathic pain. "The Clik Anchor complements our SCS percutaneous leads portfolio, and gives physicians the most comprehensive array of lead options in the market."
The Precision Plus SCS System is indicated as an aid in managing chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. For more information, visit www.ControlYourPain.com.
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.
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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 our market position, 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: Boston Scientific
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