Healthcare Industry News:  neuromodulation 

Devices Cardiology

 News Release - June 12, 2009

St. Jude Medical Announces Leading Sponsorship of Landmark Clinical Trial to Study Atrial Fibrillation

The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial is designed to determine whether or not catheter ablation is better than drug therapy for the treatment of atrial fibrillation

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced that it is the leading sponsor of the Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial. The pivotal trial, announced today by Mayo Clinic, is intended to determine the effectiveness of catheter ablation (using long, narrow tubes to non-invasively reach and destroy abnormal heart tissue) in eliminating atrial fibrillation (AF), a condition in which the upper chambers of the heart beat quickly and erratically.

“The results of the CABANA trial will be significant in shaping the future of cardiac ablation as a treatment and possible cure for AF,” said Daniel J. Starks, Chairman, President and Chief Executive Officer of St. Jude Medical. “Supporting clinical trials like CABANA is an important part of our mission of advancing the practice of medicine through medical technology to help improve patient outcomes.”

The CABANA pivotal trial will last up to six years and will study the treatment of atrial fibrillation in a total of 3,000 patients and 140 centers from around the world. It will randomize patients over three years, with half undergoing catheter ablation and half receiving rate control or rhythm control drug therapy. Douglas Packer, M.D., a cardiologist at Mayo Clinic, will be the principal investigator of the clinical trial. Prior to the launch of this trial, Dr. Packer and Mayo Clinic led a 10-center, 60-patient pilot study. The results of this pilot study will be released later this summer.

The CABANA Trial will be conducted in collaboration with the Heart Rhythm Service and Biomedical Imaging Resources at Mayo Clinic, Rochester, Minn., Duke Clinical Research Institute, Durham, N.C., and CABANA Investigators. Mayo Clinic and Drs. Packer and Richard Robb, Ph.D., Mayo Clinic, have a financial interest in a mapping technology, licensed to St. Jude Medical, that may or may not be used in this research.

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 approximately 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

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 Report on Form 10-Q for the fiscal quarter ended April 4, 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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