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Boston Scientific Announces Promising Clinical Data on New Products at the International Spine Intervention Society 20th Annual Scientific Meeting
Date:7/18/2012

NATICK, Mass., July 18, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has presented results of two studies evaluating the Infinion™ 16 Percutaneous Lead, the world's first and only 16-contact percutaneous lead for spinal cord stimulation (SCS) therapy, and the Clik™ Anchor, an innovative locking system designed to secure and reduce unwanted migration of SCS leads.  The research was presented at the International Spine Intervention Society (ISIS) 20th Annual Scientific Meeting in Las Vegas.

Results from the Infinion 16 study demonstrated that this innovative lead, used in conjunction with the Precision™ Plus SCS System, delivered significant pain relief in patients with chronic pain.  The Clik Anchor study, awarded Best Poster at the ISIS meeting, showed that this novel fixation device reduced lead migration, the most common complication associated with SCS therapy. 

"Chronic pain affects the daily lives of more than 100 million Americans each year, and tens of thousands of patients with chronic pain have found that SCS systems help them manage their pain," said Maulik Nanavaty, senior vice president and president of the Neuromodulation Division at Boston Scientific.  "The Infinion 16 Lead and Clik Anchor studies underscore our commitment to developing industry-leading technologies that advance the management of chronic pain and mitigate difficulties associated with SCS therapy."

Initial Spinal Cord Stimulation Trial Outcomes with the Infinion 16 Lead

An analysis of 25 chronic pain patients who underwent an SCS trial showed that the Infinion 16 Lead delivered significant pain relief outcomes for those patients, including reduced pain intensity (p<0.0001) and improved pain relief (p<0.0001).

"The Infinion 16 is the only lead that provides 16 contacts that can be inserted through a single, small needle with just one lead placement," said Timothy Chafin, M.D., pain management specialist at Vidant Roanoke-Chowan Hospital in North Carolina and lead author of the study.  "Added coverage of the spinal cord provides me with more options to manage my patients' chronic pain."

Additionally, 88 percent of patients temporarily implanted with the Infinion 16 Lead met the criteria for permanent SCS implantation with the Precision Plus SCS System.

Reducing Lead Migration with the Clik Anchor: A Real-World Review

Named Best Poster of ISIS 2012, an analysis of data from the Boston Scientific internal patient database, which included a cohort of more than 6,000 patients implanted with the Precision Plus SCS System, showed that the Clik Anchor reduced rates of lead revision due to lead migration by more than 40 percent when compared to the population of patients not implanted with the Clik Anchor.

"Lead migration is the most common complication of spinal cord stimulation and may lead to additional surgery to revise lead placement," said Stephen Pyles, M.D., of the Florida Pain Clinic in Ocala, Florida.  "In my clinical experience, the Clik Anchor reduces the potential for additional surgical procedures."

About the Clik Anchor

Lead migration is the most common complication of SCS.  The Clik Anchor was designed to improve lead anchoring speed and consistency through an innovative locking system.  Locking into place on the lead with a simple turn of a hex wrench, the Clik Anchor provides tactile and audible confirmation for physicians that the lead is secured.

About the Infinion 16 Percutaneous Lead

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

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 on Precision Plus technology, visit http://www.ControlYourPain.com.

About Boston Scientific Neuromodulation

Boston Scientific Neuromodulation is an innovation leader in implantable pain management technology.  The Precision Plus SCS 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 its investments in technology, clinical science, and world-class service, Boston Scientific Neuromodulation is committed to Making life smoother™ for physicians and patients. 

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: 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 our business plans, markets for our products, clinical trials and clinical outcomes, product performance and effects.  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:

Lorie Fiber
310-623-0404 (mobile)
Media Relations
Weber Shandwick
lfiber@webershandwick.com

Steven Campanini
508-652-5740 (office)
Media Relations
Boston Scientific Corporation
steven.campanini@bsci.com

Sean Wirtjes
508-652-5305 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com

 


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