Medtronic Announces Worldwide Clinical Research Efforts to Further Demonstrate Benefits of Fluid Status Monitoring for Heart Failure Patients.MINNEAPOLIS -- Medtronic (NYSE NYSE
See: New York Stock Exchange :MDT MDT
Mountain Daylight Time
MDT (in the US and Canada) Mountain Daylight Time
MDT n abbr (US) (= mountain daylight time) → ) today announced a series of worldwide clinical studies designed to further demonstrate the patient and clinician advantages of the new implantable InSync Sentry(TM) 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , accounting for approximately 1 million hospitalizations annually. The most common cause of heart failure hospitalizations is severe congestion The condition of a network when there is not enough bandwidth to support the current traffic load.
congestion - When the offered load of a data communication path exceeds the capacity. from fluid buildup in the lungs.
InSync Sentry is the world's first implantable cardiac resynchronization therapy (CRT (1) (C RunTime) See runtime library.
(2) (Cathode Ray Tube) A vacuum tube used as a display screen in a computer monitor or TV. The viewing end of the tube is coated with phosphors, which emit light when struck by electrons. ) and defibrillation Defibrillation Definition
Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. system offering automatic fluid status monitoring by measuring impedance inside the thoracic cavity thoracic cavity
or chest cavity
Second largest hollow space of the body, enclosed by the ribs, vertebral column, and breastbone and separated from the abdominal cavity by the diaphragm. , the chest area encompassing the lungs and heart. Collection and reporting of fluid status data with a breakthrough feature called OptiVol(TM) Fluid Status Monitoring, may lead to early intervention ear·ly intervention
n. Abbr. EI
A process of assessment and therapy provided to children, especially those younger than age 6, to facilitate normal cognitive and emotional development and to prevent developmental disability or delay. 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 University of Oklahoma, abbreviated OU, is a coeducational public research university located in the U.S. state of Oklahoma. Founded in 1890, it existed in Oklahoma Territory near Indian Territory 17 years before the two became the state 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 pre·dic·tive value
The likelihood that a positive test result indicates disease or that a negative test result excludes disease.
a measure used by clinicians to interpret diagnostic test results. 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 ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device.
abbr. 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 Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. . "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 de·bil·i·tat·ing
Causing a loss of strength or energy.
Weakening, or reducing the strength of.
Mentioned in: Stress Reduction 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 hospitalizations and death. The treatment of heart failure costs an estimated $40 billion per year in the United States and nearly $80 billion worldwide.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K Form 10-K
A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.
See 10-K. for the year ended April 30, 2004. Actual results may differ materially from anticipated results.