Healthcare Industry News: Mitral Valve
News Release - July 9, 2007
St. Jude Medical Announces First Enrollment in Study To Understand Appropriate Anti-Clotting Therapy After Tissue Heart Valve ImplantST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) and the Duke Clinical Research Institute (DCRI) today announced the first enrollment in a major study designed to better understand appropriate anti-clotting medication therapies for patients following implantation of tissue heart valves.
The study will gather extensive clinical evidence on the use of anti-coagulant and anti-platelet (blood-thinning) medication treatments to reduce the risk of clot formation in the early months after a tissue valve is implanted. It also will gather data on the incidence of clotting and bleeding experienced by patients during the six months after they receive a tissue valve.
Administered by the DCRI, the Anti-coagulation Strategy with Bioprosthetic Valves: Post-Operative Event Registry (ANSWER) will enroll at least 2,000 patients at 100 U.S. medical centers. Enrollment is expected to be completed over the next two years.
Eric Peterson, M.D., M.P.H., associate director and director of Cardiovascular Research at the DCRI, Durham, N.C., is the ANSWER coordinating center's principal investigator. National principal investigators include cardiac surgeons Kent Jones, M.D., chairman, Division of Cardiovascular and Thoracic Surgery, Latter Day Saints Hospital, Salt Lake City; John Laschinger, M.D., chief of Cardiac Research, Union Memorial Hospital, Baltimore; and Kenton J. Zehr, M.D., chief, Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh.
When complete, the ANSWER Registry is expected to provide the largest body of prospective clinical evidence, to date, on anti-clotting therapies prescribed following implantation of tissue valves. The ANSWER Registry will collect data from consenting adult patients who are receiving their first aortic and/or Mitral Valve replacement and are implanted with a St. Jude Medical Biocor or Biocor(TM) Supra Stented Tissue Valve. Similar clinical evidence is being collected in European centers through the ACTION Registry (Anticoagulation Treatment Influence on Postoperative Patients), initiated in 2006 and conducted by St. Jude Medical.
"By collecting data across a large community sample, the ANSWER Registry will play an important role in defining standard clinical practice," said Dr. Peterson of the DCRI. "In addition, we hope to use this information to understand what constitutes best practice."
An estimated 150,000 Americans undergo heart valve replacement annually and the majority of them receive tissue heart valves. Patients implanted with tissue valves are at risk of blood clots (and potential stroke) and bleeding during the initial post-operative period while the valve "heals." To reduce the risk of clotting, anti-coagulant or anti-platelet (blood thinning) drug regimens are typically prescribed.
Despite guidelines issued by professional organizations on post-operative treatments for valve replacement patients, there continues to be a lack of consensus on best practice in choice or duration of anti-coagulation therapies. As a result, patients receive varying regimens over varying periods of time.
"The ANSWER Registry aims to fill a critical void with solid clinical evidence," said George J. Fazio, president of St. Jude Medical's Cardiovascular Division. "St. Jude Medical is committed to providing support for studies that help advance the understanding of anti-coagulation management for patients who receive either tissue or mechanical heart valves."
St. Jude Medical previously supported the GELIA (German Experience with Low Intensity Anticoagulation) and ESCAT (Early Self-Controlled Anticoagulation Trial) studies. These studies collected data from thousands of patients in European centers and provided evidence on anti-coagulation treatments following implantation of mechanical heart valves.
The DCRI is the world's largest academic clinical research organization, combining clinical expertise, academic leadership and the full-service operational capabilities of a contract research organization. With 950 faculty and staff, the DCRI's experience includes Phase I through Phase IV clinical trials, post-market analyses and health economics.
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 more than 11,000 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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