St. Jude Medical Announces Publication of 20-year Durability in Aortic and Mitral Stented Tissue Valves

Study reports excellent long-term durability of the St. Jude Medical Biocor™ Stented Tissue Valve for mitral and aortic valve replacement.

St. Jude Medical, Inc., today announced the publication of a study on the St. Jude Medical Biocor™ Stented Tissue Valve – the second study published in recent months to report 20-year data showing excellent long-term durability of the Biocor tissue valve.

Published in the January 2009 issue of the Journal of Thoracic & Cardiovascular Surgery, this prospective study compiles data from 1,712 patients, and is one of the largest published studies of tissue valves.

Led by Pia S.U. Myken, M.D., Ph.D., Department of Cardiothoracic Surgery, Sahlgrenska University Hospital in Gothenburg, Sweden, the results of this study confirm findings previously published at 10-, 15- and 17-year follow-up intervals for the same group of patients. These studies demonstrate the valve’s excellent performance on a key measure of durability: freedom from reoperation due to structural valve deterioration (the rate at which patients remain free from the need for another operation resulting from degeneration that negatively affects the valve’s functionality).

At 20 years, the data show that 92 percent of patients more than 65 years old, whose aortic valves were replaced with the Biocor Stented Tissue Valve, remain free from reoperation due to structural valve deterioration. For patients in the same age group who received a Biocor Stented Tissue Valve in the mitral position, the rate of freedom from reoperation was 88 percent. The average age at implant was 71 years for patients who received the Biocor valve in the aortic position and 65 years for those implanted in the mitral position.

“For physicians and patients, long-term durability is the most important parameter in evaluating heart tissue valves,” said Dr. Myken. “Our 20-year data demonstrate the excellent durability of the St. Jude Medical Biocor tissue valve in both the aortic and mitral positions.”

Dr. Myken’s study confirms recent 20-year data published in the October 2008 issue of The Annals of Thoracic Surgery. That study, led by Walter Eichinger, M.D., at the German Heart Center in Munich, Germany, which evaluated Biocor valve performance in the aortic position, found the rate of freedom from reoperation for structural valve deterioration to be 86.6 percent for patients who were between 65 and 75 years of age.

“The publication of two independent 20-year studies in close succession provides compelling confirmation of the Biocor tissue valve’s long-term durability,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “These results reinforce St. Jude Medical’s leadership position as a provider of durable, long-lasting, high-quality tissue heart valves that meet the needs of physicians and their patients. We are committed to advancing technologies that provide clinically important options to the surgeon–putting more control in their hands, and helping to mitigate risk and improve outcomes.”

Physicians seek treatment options for patients with heart disease that will enable them to avoid reoperation in the future. While the excellent long-term performance of St. Jude Medical mechanical heart valves in this patient population is well documented, the 20-year durability data in both the Myken and Eichinger studies now support the use of Biocor tissue valves as an additional, viable option for patients as young as 65.

Dr. Myken’s recently published study followed 1,712 consecutive patients who received a Biocor valve for aortic or mitral valve replacement between 1983 and 2003 at Sahlgrenska University Hospital. Adhering to standardized follow-up methods, researchers received patient responses to questionnaires, conducted telephone interviews and reviewed hospital records in alternate years after valve implant for 99.9 percent of enrolled patients.

To date, more than 160,000 St. Jude Medical stented tissue valves, including both the Biocor valve, and the Epic™ Stented Tissue Valve with Linx™ AC Technology, have been implanted worldwide.


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