Boston Scientific Announces FDA Approval for LATITUDE(R) Patient Management System Software Upgrade
NATICK, Mass., May 11 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) approval for LATITUDE 6.0, a software upgrade to the Company's LATITUDE® Patient Management system. The LATITUDE system enables physicians to remotely monitor patients with implantable cardiac devices. The upgrade provides enhanced functionality, including the ability to view an expanded history of a patient's remote follow-up data.
The LATITUDE Patient Management system can detect changes in a patient's heart health status between scheduled follow-up visits and send relevant data and alerts directly to physicians. More than 160,000 patients have been enrolled on the system at more than 2,300 clinics across the U.S. The LATITUDE system is available in 15 other countries and use of the system continues to expand internationally with nearly 1,700 patients enrolled in Europe at approximately 150 clinics.
In 2009, the LATITUDE system detected more than 7,000 patients with at least one event of atrial arrhythmia. Patients with atrial arrhythmias such as atrial fibrillation, particularly those with heart failure, are at increased risk of stroke. By identifying atrial arrhythmias earlier, physicians have the opportunity to intervene with treatments that may reduce patient risks.
"Remote monitoring between regularly scheduled follow-up visits allows earlier observation of events, giving physicians the option to intervene earlier," said Kenneth Stein, M.D., Chief Medical Officer, CRM, for Boston Scientific's Cardiology, Rhythm and Vascular Group. "We welcome FDA approval of LATITUDE 6.0, which offers software improvements in response to physician feedback."
The LATITUDE Patient Management system will be demonstrated at Boston Scientific's booth (#1017) during the 31st Annual Scientific Sessions of the Heart Rhythm Society, May 13 - 15 in Denver.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products 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 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 product performance, significance of event data, our growth strategy, our operational strategy, and our market position. 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 IA- 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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SOURCE Boston Scientific Corporation
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