Boston Scientific Defibrillators Receive CE Mark for Extended Longevity
PARIS, November 20, 2012 /PRNewswire/ --
Devices Projected to Have up to Twice the Longevity of Comparable Products
Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for increased longevity projections for the INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The longevity projections are based on data submitted to the European authorities and vary for each device dependent on the model type and settings.
Projected device longevity exceeds 10 years for some models of Boston Scientific ICDs, approaches eight years for its CRT-D devices, and is up to double that of comparable competitive device models. The company supports these devices with warranties of up to 10 years*. Depending on the model, the device warranties are also up to twice as long as other currently-marketed comparable devices.
"We are pleased with the new labeling for our defibrillator products which provides doctors and patients with additional assurance about the longevity of these devices," said Michael Onuscheck, senior vice president and president of Europe, Middle East and Africa at Boston Scientific. "Boston Scientific ICDs and CRT-Ds benefit from our proprietary advanced battery technology. The new battery was first introduced in the COGNIS and TELIGEN devices in 2008 and has now been incorporated into our newest devices. This European approval confirms the confidence already expressed earlier this year by the United Stated Food and Drug Administration."
"Device longevity is of primary importance for patients with devices. As patients live longer, increased device longevity can translate to fewer replacement procedures and a lower risk of complications," said Vias Markides, consultant cardiologist and chair of Arrhythmias, Royal Brompton and Harefield NHS Foundation Trust, London. "Reducing re-intervention also has an important impact on the health care economy, offering substantial savings to service commissioners and offering operational advantages for device implanting services. Boston Scientific ICDs and CRT-D devices have shown a substantial increase in longevity projections, which is backed up by an impressive warranty."
* Warranties: INCEPTA and ENERGEN VR ICD: 10 years; INCEPTA and ENERGEN DR ICD: eight years; PUNCTUA and TELIGEN ICD: seven years; INCEPTA and ENERGEN CRT-D: six years; and PUNCTUA & COGNIS CRT-D: five years.
1. PUNCTUA™ ICD, ENERGEN™ ICD, INCEPTA™ ICD - PHYSICIAN'S TECHNICAL MANUAL
Part Number: 358362-006, 5-22-12; TELIGEN® 100 - PHYSICIAN'S TECHNICAL MANUAL
Part Number: 357449-010, 5-22-12; PUNCTUA™ CRT-D, ENERGEN™ CRT-D, INCEPTA™ CRT-D - PHYSICIAN'S TECHNICAL MANUAL Part Number: 358373-007, 5-22-12; COGNIS® 100-D - PHYSICIAN'S TECHNICAL MANUAL Part Number: 357483-012, 5-22-12
To view the Multimedia News Release including a video, backgrounders and images, please click here: http://www.epresspack.net/bsci
Visit the Boston Scientific Longevity Website here: http://www.bostonscientific-international.com/ICDlongevity
For more news about Boston Scientific please follow us on Twitter @bsc_eu_heart (https://twitter.com/BSC_EU_Heart).
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: http://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, 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.
SOURCE Boston Scientific Corporation
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