Boston Scientific Data Show Real-World Survival Rates For Implantable Cardiac Device Patients Exceed Rates From Clinical Trials

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 15 May 2009 - 1:00 PDT

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Boston Scientific Corporation (NYSE: BSX) announced data from its ALTITUDE Clinical Science program that show real-word survival rates for implantable cardiac device patients exceeding rates from clinical trials. ALTITUDE analyzes outcomes data from patients monitored by the LATITUDE(R) Patient Management system. Five-year survival rate data for patients using implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) were presented at the Heart Rhythm Society Scientific Sessions in Boston by Leslie Saxon, M.D., F.A.C.C., Chief, Cardiovascular Medicine at the Cardiovascular and Thoracic Institute, University of Southern California, and chairperson of the ALTITUDE physician panel.

Boston Scientific has enrolled more than 130,000 patients on the LATITUDE system since its introduction in 2006, making it the most rapidly adopted remote cardiac device monitoring system in the industry(1). The LATITUDE system enables physicians to schedule remote follow-ups of implantable cardiac device patients to monitor specific device information and heart health status. The system can also detect clinical events between scheduled visits and send relevant data directly to physicians. This regular, in-home monitoring offers convenience and peace of mind for patients.

Findings presented today from ALTITUDE, which analyzed nearly 86,000 patients monitored by the LATITUDE system, include:

-- Five-year survival rates for ICD patients of up to 92 percent

-- Five-year survival rates for CRT-D patients of up to 78 percent

"In contrast to clinical trials, the ALTITUDE program analyzes device therapy in real-world practice and offers insights into clinical event rates and disease progression for extensive ICD and CRT-D patient populations," said Dr. Saxon. "This observational cohort study represents the largest cardiac device patient cohort to date and clearly shows survival rates exceed those reported in randomized trials."

"Boston Scientific is known for excellence in its clinical trials, such as MADIT, MADIT II, COMPANION and MADIT-CRT," said Fred Colen, President, Boston Scientific Cardiac Rhythm Management. "We're also proud of our significant investment in physician research through post-market analysis. The ALTITUDE Clinical Science program serves physicians by enhancing their understanding of device therapy, outcomes and disease progression in real-world device patients monitored by LATITUDE."

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 clinical trials, scientific activities, product performance, competitive offerings and growth investment. 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 thereafter. 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) Data based on number of patients at three years post-launch. Data on file.

Source: Boston Scientific Corporation