ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ - News) today announced that it has completed enrollment in its European clinical trial to evaluate Trifecta™, a stented pericardial tissue heart valve.
The Trifecta clinical trial is a multi-center, prospective study, which enrolled 120 patients at six centers throughout Europe. The trial will evaluate the safety and efficacy of the Trifecta stented tissue valve as a replacement for the aortic valve, which is located between the heart’s left ventricle and the aorta, the primary vessel carrying blood from the heart to the rest of the body. Efficacy will be determined by the valve’s hemodynamic performance at 12 months, as measured by echocardiography. Hemodynamic performance is characterized by the valve’s ability to allow blood to flow through it in a manner most similar to healthy, normal heart valves.
“Completion of European enrollment in the Trifecta study marks an important milestone in our continued efforts to develop additional technologies for patients suffering from debilitating cardiac diseases,” said Frank Callaghan, president of St. Jude Medical’s Cardiovascular Division. “Our investment in the development of this tissue valve demonstrates our dedication to giving physicians the best possible options for treating valvular disease.”
An estimated 500,000 people worldwide suffer from severe, symptomatic aortic stenosis, while approximately 170,000 patients worldwide undergo aortic tissue heart valve replacements annually. Aortic valve replacement is typically indicated for patients with aortic stenosis, a narrowing of the aortic valve, or aortic regurgitation, a condition in which the valve does not close properly, allowing blood to flow back into the left ventricle.
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 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 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.
Contact:
St. Jude Medical, Inc.Investor Relations:Angela Craig, 651-756-2191acraig@sjm.comorMedia Relations:Sara Spafford, 651-756-6702sspafford@sjm.com
