Data From More Than 100,000 Boston Scientific Implantable Defibrillators Show Battery Longevity Projections Of Nine To 13 Years

NATICK, Mass., May 10, 2013 /PRNewswire/ -- New data from 100,438 patients with Boston Scientific Corporation (NYSE:BSX) implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) followed in the LATITUDE™ Patient Management System demonstrate the battery life of Boston Scientific single-chamber ICDs, dual-chamber ICDs and CRT-Ds are projected to last an average of 13.2, 11.5 and 9.2 years, respectively.[1]  

"Clinical studies show early device replacement brings an increased risk of infection and complications,[2]^,[3]^,[4]^,[5]^,[6]^,[7]" said Joe Fitzgerald, president, Cardiac Rhythm Management, Boston Scientific.  "A nine-year average projected longevity of our CRT-Ds reflects our commitment to quality and engineering excellence.  Our advances in device longevity also help reduce healthcare costs through fewer replacement surgeries due to battery depletion."

Introduced in 2008, the Boston Scientific current devices are the world's thinnest ICDs and CRT-Ds, with nearly twice the industry-standard battery capacity.  In addition, the Boston Scientific INCEPTA™ CRT-D and ENERGEN™ ICD offer the industry's longest warranty, lasting up to 10 years for some models.[8]

"While device longevity is vital to customers and patients, we believe reliability is equally important," said Kenneth Stein, M.D., chief medical officer, Cardiac Rhythm Management, Boston Scientific.  "We have paired our long-lasting ICDs and CRT-Ds with the RELIANCE defibrillator lead, which was designed to address the common issues facing ICD leads.  The reliability of the Boston Scientific ENDOTAK RELIANCE™ defibrillator lead family is unmatched in the industry."

The ENDOTAK RELIANCE family of leads has nearly twenty years of proven performance.  In fact, the ENDOTAK RELIANCE family of leads has a 98.5 percent survival probability at 10 years[9] which is better than the five-year or less survival probability of commonly used competitors' leads[10]^,[11]. The foundation of the reliability of the ENDOTAK RELIANCE has been its integrated bipolar design, abrasion-resistant silicone insulation and the unique GORE™ ePTFE coating that only Boston Scientific offers to patients and their physicians. 

"The longer we can keep patients out of the hospital the better," added Dr. Stein.  "The combination of industry-leading device longevity coupled with lead reliability provides a tangible benefit to patients.  This is yet another example of our commitment to meaningful innovation and providing solutions that improve patient quality of life."

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 www.bostonscientific.com and connect on Twitter and 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 product performance and impact, 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.

Latitude, Incepta, Energen and Endotak Reliance are unregistered or registered trademarks of Boston Scientific Corporation or its affiliates.  All other trademarks are property of their respective owners.

[1] Based on Boston Scientific LATITUDE data on File.

[2] Borleff C J, Thijssen J, Mihaly K, van Ress JB, van Erven L, et al.  PACE 2010; 33:1013-1019.

[3] Ramachandra. Impact of ICD Battery Longevity on Need for Device Replacements. PACE 2010; 33:314–319.

[4] Tarakji, Khaldoun G. et al. CIED Infections:  Presentation, Management and Patient Outcomes. Heart Rhythm Aug 2010; 7:1043-1047.

[5] Lekkerkerker, J.C. et al. Risk Factors And Time Delay Associated With Cardiac Device Infections. HEART 2009; 95:715-720. 

[6] de Bie, MK. et al. Heart Rhythm  2012; 9:494-498. 

[7] Sohail MR, et al. Mortality and Cost Associated with Cardiovascular Implantable Electronic Device Infections. Arch Intern Med 2011; 171:1821-1828.

[8] Boston Scientific Limited Warranty for Implantable Cardiac Pulse Generators.  358871-001 ML.  Accessed 5/3/2013.

[9] Boston Scientific PPR Q4 2012.  Analysis uses only models with PPR-reported survival probabilities.

[10] 6947 Sprint Quattro Secure survival probability is 98.2 percent at five years.  Medtronic PPR 2013 First Edition – Issue 68.

[11] Durata® DF4 Models 7120Q & 7121Q survival probability 98.35 percent at 35 months per Actively Monitored Study Data.  St. Jude Medical 2012 PPR 2^nd Edition.

CONTACT:

Steven Campanini
508-652-5740 (office)
Global Media Relations
Boston Scientific Corporation
[email protected]

Michael Campbell
508-650-8023 (office)
Investor Relations
Boston Scientific Corporation
[email protected]

SOURCE Boston Scientific