Study reports excellent long-term durability of the St. Jude Medical Biocor(TM) Stented Tissue Valve for mitral and aortic valve replacement
ST. PAUL, Minn.--(BUSINESS WIRE)--Jan. 15, 2009--St. Jude Medical, Inc. (NYSE:STJ) today announced the publication of a
study on the St. Jude Medical Biocor(TM) 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
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
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
To date, more than 160,000 St. Jude Medical stented tissue valves,
including both the Biocor valve, and the Epic(TM) Stented Tissue
Valve with Linx(TM) AC Technology, have been implanted worldwide.
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 13,000 people worldwide and has five major focus areas that
include: cardiac rhythm management, atrial fibrillation, cardiac
surgery, cardiology and neuromodulation. For more information, please
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CONTACT: St. Jude Medical, Inc.
Media and Investor Contact:
Angela Craig, 651-481-7789
Source: St. Jude Medical, Inc.