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Boston Scientific Corporation (BSX) Completes First-in-Human Clinical Trial of the IntellaTip MiFi™ XP Ablation Catheter for Patients With Type 1 Atrial Flutter


5/6/2013 10:04:15 AM

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NATICK, Mass., May 6, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) completed a first-in-human clinical trial utilizing the IntellaTip MiFi XP Ablation Catheter for the treatment of type 1 atrial flutter, an arrhythmia originating in the right atrium of the heart that affects nearly one million people in the United States. This single center feasibility trial enrolled 10 patients and was led by Prash Sanders, MBBS, PhD, FHRS, director of the Centre for Heart Rhythm Disorders at the University of Adelaide and the Royal Adelaide Hospital.

Patients with type 1 atrial flutter may exhibit symptoms that include palpitations, shortness of breath, fatigue, lightheadedness and fainting. Catheter ablation, a procedure in which localized electrical energy is delivered into the heart tissue aimed at restoring the continuous normal rhythm, has become a first-line treatment approach for patients with recurrent type 1 atrial flutter and demonstrates more successful short- and long-term outcomes compared to anti-arrhythmic drug therapy.

The IntellaTip MiFi XP Catheter is the first addition to the IntellaTip family of ablation catheters Boston Scientific expects to unveil over the coming years. This new line of ablation catheters is designed to provide physicians with high resolution, precise, multidimensional information through sophisticated micro-sensors at the tip of the catheter.

"The IntellaTip MiFi XP Catheter provided all of the benefits of a large tip catheter while allowing significantly more detailed mapping," said Professor Sanders. "The catheter handling was intuitive and I found that the mapping capabilities gave me greater ability to identify gaps and know where to ablate. Potentially reflecting this, we had several procedures where the ablation time was quite short compared to conventional ablation technology."

"We believe the design of the IntellaTip MiFi technology will redefine the quality of critical electrical information that electrophysiologists depend on during ablation procedures," said Pete Sommerness, general manager, Electrophysiology, Boston Scientific. "This technology demonstrates our commitment to providing electrophysiologists with innovative solutions to help improve the health of patients around the world."

Electrophysiology is a $2.5 billion market growing at a double-digit pace and represents a key growth area for Boston Scientific. The IntellaTip MiFi XP is an investigational device and is not available for sale.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

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, product performance and importance, 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:

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

Michael Campbell
508-650-8023 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com

SOURCE Boston Scientific Corporation



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