NATICK, Mass., April 10, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces CE Mark approval and European market launch of its INGENIO™ and ADVANTIO™ pacemakers and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-P).  One of the first implants of the INGENIO pacemaker occurred last week by Marc Burban, M.D., at the Nouvelles Cliniques Nantaises in Nantes, France.

"The INGENIO family of pacemakers represents a significant investment in long-term innovation for pacing technologies and defines a new era of pacing for our company," said Joe Fitzgerald, senior vice president and president of the Boston Scientific Cardiac Rhythm Management group.  "In addition, we expect to launch a series of devices with expanded capabilities, that would include remote monitoring, advanced heart failure diagnostics and compatibility with magnetic resonance imaging systems – all designed to provide innovative new features for patient health and well-being."

Pacemakers are designed to treat bradycardia, a condition in which the heart beats too slowly -- usually less than 60 beats per minute -- depriving the body of sufficient oxygen.  The INGENIO and ADVANTIO pacemakers also feature RightRate™ pacing technology designed to treat chronotropic incompetence (CI).  CI is the inability of the heart to regulate its rate appropriately in response to physical activity, which may cause patients to feel tired or short of breath during daily activities such as walking or going up a flight of stairs.  RightRate employs Boston Scientific's minute ventilation (MV) sensor, the only sensor clinically proven to restore chronotropic competence, and adds programming options to promote ease of use and in-clinic time savings.  

"The INGENIO device enables physicians to treat pacemaker patients with an advanced and comprehensive set of therapies," said Dr. Burban.  "The new RightRate pacing is easy to optimize and is designed to provide needed heart rates for patients to help them feel less fatigued during physical activity."

The INGENIO family of pacemakers and CRT-Ps is expected to be compatible with Boston Scientific's new LATITUDE™ NXT Remote Patient Management system, which would enable physicians to conduct remote follow-ups of these device patients to monitor specific pacemaker information and heart health status.  The system is designed to detect clinical events between scheduled visits and send relevant data directly to a secure physician-accessible website via landline or cellular-based telephone technology. 

The INGENIO and ADVANTIO pacemakers are currently under review by the U.S. Food and Drug Administration, and are currently not available for sale in the United States.

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 new product launches and launch cadence, regulatory approvals, development and commercialization of enhanced technologies, product performance and effects, clinical outcomes, our business plans 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 Corporation