Healthcare Industry News: Trifecta
News Release - July 24, 2007
St. Jude Medical Announces First Clinical Trial Implant of Trifecta Stented Tissue Heart ValveST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced the first patient implant in its clinical trial of Trifecta(TM), a new investigational stented, pericardial tissue heart valve.
The patient is the first of approximately 500 adult patients who will participate in the study. The first implant was performed by Hartzell V. Schaff, M.D., chair, Cardiovascular Surgery Division, Mayo Clinic, Rochester, Minn., and the trial's principal investigator.
The trial will evaluate the safety and efficacy of Trifecta as a replacement for the aortic valve, which is located between the heart's left ventricle and the aorta (the vessel which carries blood from the heart to the rest of the body). Efficacy will be determined by the valve's hemodynamic performance (its ability to deliver blood flow to accommodate the body's needs).
"The promise of the Trifecta tissue valve to potentially deliver superior hemodynamic performance to currently available stented or stentless aortic valves is very exciting," said Tirone E. David, M.D., Head of the Division of Cardiovascular Surgery, Toronto General Hospital, Toronto, who is an investigator in the trial.
"Studies for new technologies that extend the portfolio of tissue valve solutions available to cardiac surgeons are critical to helping patients, " said Dr. Schaff. "With each innovation, physicians and patients gain a broader range of solutions from which to tailor individual treatment."
The Trifecta clinical trial is a multi-center, prospective study enrolling patients at approximately 22 medical centers in the U.S. and Canada. It is being conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption.
An estimated 170,000 patients worldwide undergo aortic tissue heart valve replacements annually - and the number is expected to grow as the population ages. Aortic valve replacement is typically indicated for patients with aortic stenosis (a narrowing of the aortic valve) or aortic regurgitation (in which the valve does not close tightly and blood flows back into the left ventricle).
Long recognized as a leader in mechanical heart valves, St. Jude Medical continues to expand its expertise in the tissue valve segment. The company currently markets the Biocor(TM) and Biocor(TM) Supra Tissue Valves. The company's Epic(TM) Tissue Valve with proprietary Linx(TM) anti-calcification technology was introduced in Europe and Canada in 2000.
"St. Jude Medical's research and investment in an expanding portfolio of valve solutions and other cardiac surgery- related technologies demonstrates our ongoing commitment to cardiac surgeons and their patients," said George J. Fazio, president of St. Jude Medical's Cardiovascular Division.
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 www.sjm.com.
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 May 9, 2007 (see pages 23-24). 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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