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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