Worldwide research to demonstrate benefits of fluid status monitoring
for heart failure patients
27 April 2005
Minneapolis, USA. Medtronic (NYSE:MDT) has announced a series of
worldwide clinical studies designed to further demonstrate the patient and
clinician advantages of the new implantable InSync Sentry system to help
detect and manage worsening heart failure.
Worsening heart failure is the number one reason for hospitalization in
people 65 years or older in the United States, accounting for approximately
1 million hospitalisations annually. The most common cause of heart failure
hospitalisations is severe congestion from fluid build-up in the lungs.
InSync Sentry is the world’s first implantable cardiac resynchronization
therapy (CRT) and defibrillation system offering automatic fluid status
monitoring by measuring impedance inside the thoracic cavity, the chest area
encompassing the lungs and heart. Collection and reporting of fluid status
data with a breakthrough feature called OptiVol Fluid Status Monitoring, may
lead to early intervention to prevent heart failure progression and
hospitalization. Since the first commercial implants in June 2004, the
InSync Sentry system has been implanted in more than 5,000 patients
worldwide. Some U.S. centers began implanting the system in December 2004,
and Medtronic introduced it to all U.S. clinician customers in February
2005.
“Heart failure is a progressive condition characterized by a fluctuating
course with life-threatening acute destabilizations. Monitoring devices like
InSync Sentry, which can identify precursors of such acute events, may help
to prevent hospitalizations and reduce costs. Pulmonary congestion is the
most important indicator of heart failure, and monitoring it may offer a
unique opportunity to protect heart failure patients,” said Prof. Luigi
Tavazzi, M.D., head of the Cardiology Division at the University Hospital of
Pavia, Italy.
“The OptiVol fluid status monitoring feature in InSync Sentry has the
potential to dramatically change the way heart failure is managed,” said
Philip Adamson, M.D., associate professor of medicine at the University of
Oklahoma Health Sciences Center in Oklahoma City, Okla. “This research will
shed further light on how the unique monitoring and diagnostics in this
system can help improve patient outcomes.”
Medtronic sponsored pioneering studies of cardiac resynchronization
therapy in the 1990s and continues to lead the medical device industry in
research and development to improve the management of heart failure. The
following new and ongoing clinical trials build on the success of the
completed MIDHeFT (Medtronic Impedance Diagnostics in Heart Failure Trial)
and FAST (Fluid Accumulation Status Trial) studies. MIDHeFT and FAST
demonstrated the safe and effective use of implantable device-based
intrathoracic impedance measurement. The studies identified below, which
will include total of approximately 2,000 patients, further evaluate the
benefits of the OptiVol technology.
- SENSE-HF (Sensitivity of the InSync Sentry OptiVol Feature for the
Prediction of Heart Failure) — A prospective study currently underway in
Europe, SENSE HF will involve approximately 40 European institutions
with planned future expansion to another 40 institutions in the United
States. The global trial will enroll up to 750 patients, to evaluate the
sensitivity and predictive value of OptiVol fluid status data. The first
patient was enrolled in SENSE-HF in March 2005 at the Slovak Institute
of Cardiac and Vascular Disease in Bratislava, Slovakia, by Prof. Robert
Hatala, M.D., and Peter Margitfalvi, M.D.
- FAST Expansion — This study, an extension of the FAST study conducted
in 2004, will gather additional data on the use of the OptiVol algorithm
at up to 20 centers worldwide. Patient enrollment began in January 2005
and will reach approximately 200 patients, some of who will receive a
Medtronic ICD using the OptiVol feature without CRT.
- PARTNERS HF (Program to Access and Review Trending INformation and
Evaluate CoRelation to Symptoms in Patients With Heart Failure) — This
U.S. study, which began in June 2004, is evaluating the InSync Sentry
system in clinical practice. PARTNERS HF will enroll approximately 1,000
patients at 100 U.S. sites.
- European Observational InSync Sentry Study — This European study,
which began in July 2004, is collecting data from patients who have an
InSync Sentry system to asses the clinical value of the OptiVol
diagnostic capability. Up to 500 patients are being enrolled at 60
European centers.
“Multifaceted, disease management device solutions will be key to the
future of heart failure management,” said Steve Mahle, president of
Medtronic Cardiac Rhythm Management. “Physicians are extremely enthusiastic
about InSync Sentry and OptiVol, and our ongoing scientific studies will
help increase the understanding of the role of heart failure monitoring in
improving the care of heart failure patients.”
Approximately 22 million people worldwide suffer from heart failure,
including 5 million Americans. Heart failure is a progressive and
debilitating condition, often resulting in dysynchronous beating of the
heart’s lower chambers and low blood ejection that places victims at risk
for a poor quality of life, frequent hospitalisations and death. The
treatment of heart failure costs an estimated $40 billion per year in the
United States and nearly $80 billion worldwide.
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