St. Jude Medical Announces Results From RethinQ Clinical Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials
Article Date: 08 Nov 2007 - 4:00 PDT

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St. Jude Medical, Inc. (NYSE:STJ) announced that the Resynchronization Therapy In Normal QRS (RethinQ) Trial, which studied a subgroup of heart failure patients, most of whom are currently not indicated for cardiac resynchronization therapy (CRT), did not reach its primary effectiveness endpoint of improved oxygen consumption at peak exercise (peak VO2). While there was a statistically significant improvement in NYHA class, a secondary endpoint, there was no improvement in quality-of-life, 6-minute walk or echocardiographic measures in the patients who received CRT.

Data were presented during a late-breaking clinical trial session at the American Heart Association Scientific Sessions 2007 in Orlando, Fla., by Principal Investigator John F. Beshai, M.D., director, Pacemaker and Defibrillator Services, and assistant professor of medicine at the University of Chicago School of Medicine.

The RethinQ study, which followed 172 patients for six months, was designed to determine whether CRT can help heart failure patients with a narrow QRS complex (the time required for the heart muscle to contract, as measured by electrocardiogram) and left ventricular mechanical dyssynchrony (when the heart's main pumping chambers, the ventricles, do not contract together efficiently). Patients with a wide QRS already are indicated for CRT therapy. In the RethinQ study, narrow QRS was defined as 130 milliseconds or less (120 milliseconds or less is considered normal).

Notably, the subgroup of patients with QRS duration between 120 and 130 milliseconds showed a statistically-significant benefit from CRT, as measured by the primary endpoint of exercise duration. This patient subgroup already is indicated for CRT, and this finding supports previous research on this patient subgroup.

Previous studies have suggested, but not proven, that patients with a narrow QRS and with evidence of mechanical dyssynchrony may benefit from CRT. "While there may be patients with a narrow QRS who can benefit from CRT therapy, the measures of dyssynchrony used in the RethinQ study did not identify them," said Dr. Beshai. "These new data are helpful for all heart failure physicians as we continue to determine the best criteria for assessing who will most benefit from CRT therapy."

"Heart failure remains one of the leading causes of death in the U. S., underscoring the significant need for more information about potential treatment options," said Mark D. Carlson, M.D., chief medical officer and senior vice president of clinical affairs in St. Jude Medical's Cardiac Rhythm Management Division. "RethinQ will help guide future studies to identify patients who may benefit from ICD and CRT therapy, and adds valuable information to enhance our ability to improve patient outcomes."

Heart failure is a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood to the body. About 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed each year.

CRT is a therapy that stimulates both the right and left side of the heart to improve the heart's ability to pump. Current eligibility requirements for implanting a CRT system focus on ejection fraction, (the amount of blood the heart pumps from the ventricle with each beat), NYHA Class (severity of heart failure symptoms) and QRS duration (measurement of the heart's electrical dyssynchrony).

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit http://www.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 Company's Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Report on Form 10-Q filed on August 9, 2007 (see pages 26-29). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

St. Jude Medical