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Devices Cardiology

 News Release - January 15, 2010

St. Jude Medical Announces Sponsorship of SCD-HeFT 10-Year Follow-Up Study

New study will revisit patients from the groundbreaking SCD-HeFT trial to collect long-term data regarding the efficacy of ICDs in heart failure patients

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced it will sponsor the SCD-HeFT 10-Year Follow-up Study, along with the National Heart, Lung, and Blood Institute (NHLBI) – part of the National Institutes of Health. The study will revisit 1,855 patients who participated in the original SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) to determine long-term outcomes 10 years after their last recorded follow-up. The SCD-HeFT 10-Year Follow-up Study will be led by Dr. Gust H. Bardy at the Seattle Institute for Cardiac Research (SICR), who was also the principal investigator in the original SCD-HeFT.

The original SCD-HeFT study proved the effectiveness of ICD therapy over placebo or amiodarone (a medication used to treat irregular heartbeats) for a specific population of patients, and was instrumental in changing the national reimbursement policy for ICD therapy. The SCD-HeFT outcome findings remain a key reference point for all other ICD evaluations for patients with congestive heart failure (HF). The trial was conducted from 1997-2003 and studied 2,521 patients with HF for an average follow-up period of 45.5 months. It was and remains the largest, longest and only placebo-controlled, randomized, multicenter trial of implantable cardioverter defibrillator (ICD) therapy.

At the time of the presentation of the SCD-HeFT findings in March 2004, the patients who had not yet received an ICD were given the option to receive one. It is estimated, however, that few of the patients in the placebo or amiodarone groups ultimately received an ICD, essentially maintaining the original study groups of HF patients treated either with ICD or non-ICD therapies. As a result, long-term results of these two patient groups can likely still provide significant findings regarding the long-term efficacy of ICD therapy.

Today marks the median 10-year anniversary of follow-up for the SCD-HeFT population. The SCD-HeFT 10-Year Follow-up Study will attempt to investigate all surviving patients and those who have succumbed since the end of the original trial by recontacting the 148 institutions participating in the trial (136 in the U.S., 11 in Canada and one in New Zealand). The follow-up data obtained in this project will be merged with the original SCD-HeFT database collected during the original trial, thus providing a long-term follow-up profile on all patients that were enrolled.

“The outcome of SCD-HeFT changed medical practice, but despite the virtues of the trial, many key questions remain regarding long-term efficacy, complications and cost of ICD therapy,” said Dr. Bardy. “We believe the results of this study have the potential to help direct long-term ICD management for the foreseeable future.”

The primary goals of the SCD-HeFT 10-Year Follow-up Study are:

To compare 10-year mortality data of the remaining 1,855 SCD-HeFT patients in the three arms of the trial (ICD, placebo and amiodarone) since the close of the follow-up on Oct. 31, 2003.

To obtain outcome data in the major subgroups of SCD-HeFT: ischemic versus non-ischemic; New York Heart Association (NYHA) Class II HF versus NYHA Class III HF; and in women and minorities.

To obtain 10-year ICD use rates, complication rates, lead failure rates and replacement rates.

To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients.

To obtain 10-year hospitalization and major procedure data.

To obtain 10-year quality of life data.

“We believe the patient groups examined in SCD-HeFT can provide additional insights regarding the long-term benefits of ICD therapies,” said Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division. “Our sponsorship of this study demonstrates our commitment to advancing the practice of medicine by providing physicians with clinically relevant information that has an impact the decisions they make about treating patients with heart failure.”

The original SCD-HeFT, also sponsored by the NHLBI, with supplementary sponsorship by Medtronic and Wyeth Ayerst, provided solid data to the Centers for Medicare and Medicaid Services who approved payment of ICD therapy in ischemic and non-ischemic systolic dysfunction patients with left ventricular ejection fractions (EF) = 35% and with NYHA Class II and Class III congestive HF. Other studies, such as the Multicenter Automatic Defibrillator Implantation Trial 2 (MADIT-II) eight-year study, sponsored by Boston Scientific, have also demonstrated the long-term mortality benefits of ICD therapy – that study found unadjusted mortality figures at eight years in patients with prior myocardial infarction were 45% for the ICD recipients and 61% for those in the control group.

Heart failure occurs when the heart is unable to pump enough blood to meet the body’s demands. It usually occurs due to progressive dysfunction of the heart muscle over time, rather than an acute and abrupt event. Heart failure results in the build-up of fluids, or congestion, throughout the body, which can lead to shortness of breath, swelling, and potentially lethal heart rhythm abnormalities. Over five million Americans have HF with 550,000 new cases diagnosed each year. The disease is one of the most costly to the U.S. healthcare system, costing an estimated $33.2 billion in 2007.

An ICD is a small device implanted in the chest to treat potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD). Nearly 1,000 people every day and more than 350,000 every year in the U.S. die from SCD. An ICD delivers potentially life-saving therapy from the device to the patient's heart through an insulated wire or lead.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Quarterly Reports on Form 10-Q for the fiscal quarters ended April 4, 2009, July 4, 2009 and October 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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