TISSUE VALVE GETS EUROPEAN AND CANADIAN APPROVALS.St. Jude Medical St. Jude Medical, Inc. NYSE: STJ is a $2.9 billion global cardiovascular device company, with headquarters in St. Paul, Minnesota, United States. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. , Inc. (NYSE NYSE See: New York Stock Exchange :STJ STJ Superior Tribunal de Justica (Brazil) STJ Supremo Tribunal de Justiça (Portugal) STJ Superconducting Tunnel Junction STJ San Giljan (postal locality, Malta) ), St. Paul, Minn., has received Communaute Europeenne (CE) Mark approval for its next-generation stentless tissue valve, the Toronto Root bioprosthesis, and will begin a limited European market launch. St. Jude Medical has also received Canadian Clinical Trial approval for the Toronto Root(TM)bioprosthesis, to begin at Toronto General Hospital The Toronto General Hospital (TGH), part of the University Health Network, is a major teaching hospital in downtown Toronto, Canada. It is located in the Discovery District, directly north of the Hospital for Sick Children, across Gerrard Street West, and east of Princess in Toronto, Ontario, Canada. The Toronto Root(TM) bioprosthesis builds on St. Jude Medical's highly successful Toronto SPV SPV sheeppox virus. (R) valve, the world's leading stentless porcine tissue valve. The Toronto SPV(R) valve offers excellent hemodynamic he·mo·dy·nam·ics n. (used with a sing. verb) The study of the forces involved in the circulation of blood. he performance, superior patient survival rates and quicker patient recovery times compared to conventional stented tissue valves. The Toronto Root(TM) bioprosthesis, a stentless aortic root bioprosthesis, is used in procedures where aortic root disease accompanies valve disease. The Toronto Root(TM) bioprosthesis combines the proven advantages of the Toronto SPV(R) valve with the added benefit of St. Jude Medical's unique BiLinx(TM) anticalcification technology, the only technology designed to reduce calcification calcification /cal·ci·fi·ca·tion/ (kal?si-fi-ka´shun) the deposit of calcium salts in a tissue. dystrophic calcification on the aortic wall tissue as well as the aortic leaflets. The Toronto Root(TM) bioprosthesis also provides improved tissue handling. Dr. Tirone E. David, Head, Division of Cardiovascular Surgery, Toronto General Hospital, and the developer of the Toronto SPV(R) valve, implanted the first Toronto Root(TM) bioprosthesis in Canada as part of the clinical study. The patient, a 75-year-old male with aortic valve disease and dilated aortic root, required replacement of both the valve and root. "The handling characteristics of the Toronto Root(TM) bioprosthesis are excellent and I am pleased to have an aortic valve with anticalcification treatment in both the arterial wall and cusps, which may extend its durability," said Dr. David. Professor Fredrich Mohr, chairman of Cardiac Surgery and Medical director of the Heart Center, University of Leipzig The University of Leipzig (German Universität Leipzig), located in Leipzig in the Free State of Saxony (former Kingdom of Saxony), Germany, is one of the oldest universities in Europe. , Leipzig, Germany, performed the first two Toronto Root(TM) bioprosthesis implants in Europe following CE Mark approval. Professor Mohr and his colleague, Dr. Thomas Walther, were involved with the initial in vivo efficacy testing of the BiLinx(TM) anticalcification technology. The results of their research, comparing BiLinx(TM) to other competitive technologies, were published in the December 1998 supplement to The Annals of Thoracic Surgery. "From the experimental work done in my center, we found it essential that maximum anticalcificant properties are on both the leaflets and the aortic wall, since these are considered a functional unit in stentless bioprostheses. The new Toronto Root(TM) bioprosthesis with the BiLinx(TM) anticalcification therapy may provide an optimal substitute for valve replacements for some younger patients," Dr. Mohr added. St. Jude Medical's BiLinx(TM)technology, licensed from the University of Michigan (body, education) University of Michigan - A large cosmopolitan university in the Midwest USA. Over 50000 students are enrolled at the University of Michigan's three campuses. The students come from 50 states and over 100 foreign countries. , was developed by Dr. Robert Levy, director of Cardiology, The Children's Hospital of Philadelphia The Children's Hospital of Philadelphia is one of the largest and oldest children's hospitals in the world. "CHOP" has been ranked as the best children's hospital in the United States by U.S. News & World Report and Child Magazine in recent years. . Dr. Levy is a leading global authority on anticalcification technology and has authored numerous articles on the clinical benefits of this technology. "We're pleased to collaborate with world-renowned medical researchers like Dr. David, Professor Mohr and Dr. Levy to continue to bring leading tissue valve technologies to market," said Steven J. Healy, President of St. Jude Medical's Cardiac Surgery Division. "The Toronto Root(TM) bioprosthesis, featuring our BiLinx(TM) anticalcification technology, continues our commitment to provide the best solutions for heart valve disease with the broadest line of heart valve replacement Heart Valve Replacement Definition Heart valve replacement is a surgical procedure during which surgeons remove a damaged valve from the heart and substitute a healthy one. and repair products available from any supplier." St. Jude Medical heart valve replacement and repair products are involved in more than 40 percent of all valve procedures worldwide. For 25 years, the company has been the global leader with its mechanical heart valve product line. The company recently broadened the technology it offers cardiac surgeons with the first launch of its new sutureless connector devices for coronary bypass surgery Coronary bypass surgery A surgical procedure which places a shunt to allow blood to travel from the aorta to a branch of the coronary artery at a point past an obstruction. Mentioned in: Cardiac Catheterization, Thallium Heart Scan - the Symmetry(TM) Bypass System Aortic Connector - which could dramatically simplify and change the nature of bypass surgery. St. Jude Medical, Inc. is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value. For more information, visit http://www.sjm.com or call 651/766-3029. |
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