|By PR Newswire||
|September 24, 2012 12:00 AM EDT||
- RELIANCE® 4-FRONT™ Lead Designed to Streamline Surgical Procedure for Treatment of Heart Failure and Sudden Cardiac Arrest
PARIS, Sept. 24, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received regulatory approval to market the RELIANCE® 4-FRONT™ lead, its next generation implantable defibrillation lead now available in Europe and Asia. Defibrillation leads are insulated wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator to the heart for treatment of heart failure and sudden cardiac arrest.
The RELIANCE 4-FRONT lead is built upon the demonstrated performance and reliability of the RELIANCE lead platform with design enhancements intended to simplify the implant procedure. With more than 350,000 implants worldwide, RELIANCE leads have demonstrated a 98.9 percent survival probability at 8 years(1).
"Leveraging the RELIANCE platform, we made a series of targeted design enhancements with RELIANCE 4-FRONT to improve and simplify implantation," said Kenneth Stein, M.D., chief medical officer of Boston Scientific's Cardiac Rhythm Management Group. "RELIANCE 4-FRONT represents our continued dedication to product innovation to meet the needs of patients and physicians."
Features of the new RELIANCE 4-FRONT lead include a modest size reduction in the lead body to improve handling and maneuverability while maintaining insulation thickness and reliability. IROX, a fractal coating, has been added to enhance electrical properties and lower pacing thresholds. The RELIANCE 4-FRONT lead also features a secured GORE™ coating, designed to prevent tissue ingrowth into the defibrillation coils. Adhering the GORE coating to the new lead simplifies implantation by eliminating steps in the current procedure.
RELIANCE 4-FRONT is not available for sale in the United States.
RELIANCE 4-FRONT in Asia
In Asia, one of the world's fastest-growing ICD markets, the first two implants of the RELIANCE 4-FRONT lead were performed by Razali Bin Omar, M.D. and Azlan Hussin, M.D. at the Institute Jantung Negara Hospital in Kuala Lumpu, Malaysia.
"As a long time user of the RELIANCE family of leads, I am pleased to see that the new lead builds upon the dependability I've come to appreciate with this platform," said Dr. Razali, Director of Clinical Electrophysiology and Pacemaker Service Department of Cardiology at the National Heart Institute in Kuala Lumpur, Malaysia. "The RELIANCE 4-FRONT lead handles and maneuvers well during implantation, resulting in a smooth and efficient procedure."
RELIANCE 4-FRONT in Europe
In Europe, a market where lead reliability is increasingly becoming a topic of focus, Boston Scientific is proud to be providing one of the most reliable leads on the market today, while continuing to strive for improvement through new technology. Maurizio Gasparini, M.D., Director of Electrophysiology and Pacing Department at Humanitas hospital in Rozzano, Italy is one of the first implanters in Europe and one of the most experienced physicians with this technology.
"Boston Scientific has established itself as a leader in lead reliability through the RELIANCE family of leads," said Dr. Gasparini. "RELIANCE 4-FRONT, the latest addition to this family, provides consistent outcomes and handles very well during the implantation procedure."
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 product performance and impact and our business plans. 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.
(1) Survival probability is comprised of all RELIANCE and RELIANCE G models combined as one population. Data source and data cut off is based on the BSC Q2 2012 Product Performance report. Data and calculations on file.
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