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First Implant of Boston Scientific Vitalio(TM) Pacemaker Takes Place in Europe


News provided by

Boston Scientific

26 Jun, 2013, 06:00 GMT

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PARIS, June 26, 2013 /PRNewswire/ --

The first patient implant of the Boston Scientific Corporation (NYSE: BSX) VITALIOTM pacemaker was performed at ZGT Hengelo in Hengelo, the Netherlands.  In addition to a comprehensive suite of features designed to optimize cardiac pacing, VITALIO features the Boston Scientific innovative AP Scan™ technology designed to help physicians identify patients with severe sleep apnea.  Sleep apnea is a breathing disorder which, if left untreated, may lead to increased risk of high blood pressure, heart attack, stroke and heart failure.

"With the VITALIO device, we are able to gain insight into the patient's sleep apnea status," stated  Salah Said, M.D., cardiologist, ZGT Hengelo, who performed the procedure. "It can help us potentially identify which patients may be suffering from sleep apnea and can also help us understand if prescribed sleep apnea treatments are having an impact."  

While sleep apnea is one of the most common comorbidities in patients with cardiovascular disease, and affects about 60 percent of those patients, as many as 80 percent of them remain undiagnosed.  Sleep apnea is linked to a quadrupled risk of atrial fibrillation and a doubled risk of heart failure morbidity and mortality.  

Dr. Said works together with neurologists, ENTs, and pulmonologists to treat sleep apnea patients with a collaborative approach.  AP Scan is one tool that allows the team to understand if the treatment pathway is helping the patient's overall sleep apnea status.  Effective therapies are available to reduce sleep apnea and related effects, especially for obstructive sleep apnea, a type of sleep apnea in which the patient has pauses in breathing due to obstruction of the airways.  

"Boston Scientific is focused on innovation and we are pleased to offer a broader portfolio for comorbidity management in the pacemaker population," said Michael Onuscheck, senior vice president and president of Europe, Middle East and Africa at Boston Scientific.  "The VITALIO device is designed to provide a range of tools that can help physicians detect comorbidities earlier.  This technology demonstrates our commitment to helping clinicians deliver the care and treatment their patients need."

In addition to AP Scan, VITALIO follows the patient's respiration with features such as RightRate™ and Respiratory Rate Trend for ensuring that patients receive pacing when they need it, at the rate they need it. VITALIO also offers radio-frequency (RF), which allows for efficiencies at implant and in follow-up, while allowing patients to automatically and wirelessly transmit important data about their health status to their physician.  VITALIO is also MR-conditional, enabling patients to undergo full-body magnetic resonance imaging (MRI) scans for other health issues.

The device is also available in an Extended Longevity (EL) model with the biggest battery capacity and longest longevity on the market, built upon the same battery technology as the latest generation of the Boston Scientific implantable cardiac defibrillators (ICDs).  

The VITALIO device has received the CE Mark and FDA approval.  

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 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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