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New Boston Scientific Pacemaker Family Features Technology for Adapting Pacing to Respiration


News provided by

Boston Scientific

25 Jun, 2013, 06:00 GMT

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PARIS, June 25, 2013 /PRNewswire/ --

Boston Scientific Corporation (NYSE: BSX) is launching a new family of pacemakers in Europe.  These pacemakers monitor respiration, adjust pacing accordingly, and support insight into the patient's overall heart failure status.  Comprising of the INLIVEN[TM] cardiac resynchronization therapy pacemaker (CRT-P) that synchronizes the heart chambers, and the VITALIO[TM] and FORMIO[TM] pacing systems, the new family of devices offers clinicians a comprehensive set of tools for the management of heart failure and related comorbidities.

Pacing systems are designed to treat bradycardia, a condition in which the heart beats too slowly, depriving the body of sufficient oxygen, whereas CRT-P systems are designed to treat heart failure patients.    

"The new family of devices is able to offer a unique perspective on the patient's pacing status by monitoring cardio-respiratory signals for broader co-morbidity management," said Jean-Benoît Le Polain de Waroux, professor, Cliniques Universitaires Saint-Luc in Brussels, Belgium, and an investigator in the approval studies for the devices.  "The technology is able to adapt the pacing rate to meet the patient's metabolic needs when his or her respiration is increasing, as during exercise."  

Each of the devices features the Boston Scientific RightRate™ technology to adapt the pacing rate to changes in respiration.  All three devices include AP Scan™, a technology which helps physicians identify and evaluate patients with severe sleep apnea, one of the most prevalent comorbidities in the pacemaker population.  The whole family of devices includes radio-frequency (RF) technology, which helps increase the efficiencies of the device implant and periodic in-clinic patient follow-ups.  RF technology helps ensure that patients are able to send critical diagnostic health information wirelessly and automatically to their physicians through a monitor at their home.     

In addition, FORMIO includes a full range of features that monitor, track and trend physiological markers related to heart failure, making this device specifically suited to assist in diagnosing patients who are at higher risk of heart failure.  These can include those with atrio-ventricular block, a condition in which there is a longer-than-normal delay between the contractions of the heart's chambers.  With AP Scan, Respiratory Rate Trend, Heart Rate Variability diagnostics and remote home monitoring via the Latitude™ NXT system, FORMIO may help physicians detect changes earlier and make proactive decisions, with the aim of positively impacting clinical outcomes.  The new devices also offer an MR-conditional platform, allowing patients to undergo full-body magnetic resonance imaging (MRI) scans.

"We are now able to offer a full portfolio of bradycardia and heart failure devices," said Michael Onuscheck, senior vice president and president of Europe, Middle East and Africa at Boston Scientific.  "With our new family of devices, we can provide physicians with diagnostic and therapeutic tools based on a physiological parameter such as respiration."  

INLIVEN, VITALIO and FORMIO have received the CE Mark.   VITALIO and FORMIO are also approved in the United States.  

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 us at http://www.bostonscientific.com.  For more information, visit us at http://www.bostonscientific.com or connect with us on Twitter or 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 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.

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