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.--(BUSINESS WIRE)--Jun. 12, 2009--
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 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
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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, Inc.
St. Jude Medical, Inc.
Angela Craig, 651-481-7789
acraig@sjm.com