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Evidence Supports Utility of Remote Patient Management and Fluid Monitoring Alerts to Potentially Reduce Heart Failure Hospitalisations


Medtronic OptiVol Alerts and CareLink Remote Patient Management Network May Give Physicians Early Warning to Intervene in Patients’ Treatment

MINNEAPOLIS and MUNICH, Germany – 1 September 2008 – More than 22 million people worldwide suffer from heart failure1, and most heart failure hospitalisations are due to excessive fluid accumulation in the chest cavity. New data presented at the European Society of Cardiology (ESC) Congress shows that Medtronic, Inc. (NYSE: MDT) cardiac devices equipped with OptiVol® Fluid Status Monitoring Alerts™ may give physicians advance warning of their heart failure patients’ worsening condition, thus reducing the rate of heart failure hospitalisations and clinically relevant events. Two year follow-up data, presented by Dr. Maurizio Landolina of Italy, shows this may be as much as a 50 percent reduction. (OptiVol Alerts are currently investigational in the United States.)

“Heart failure is a progressive condition, frequently marked by worsening symptoms such as fluid build-up in the chest cavity, which often must be addressed in hospital,” said Dr. Landolina of Fondazione Policlinico S. Matteo IRCCS, in Pavia, Italy. “Our research team concluded that devices with OptiVol may detect this decompensation in a broad population of heart failure patients. By allowing the chance for timely discovery and prompt intervention, the alerts could lead to a reduced number of events such as heart failure hospitalisations.”

How It Works

OptiVol Fluid Status Monitoring is found only on Medtronic cardiac resynchronisation therapy-defibrillators (CRT-Ds) and implantable cardioverter-defibrillators (ICDs). It uses low electrical pulses that travel across the thoracic cavity (the chest area encompassing the lungs and heart) to measure the level of resistance, indicating fluid in the chest – a common symptom of heart failure. Since normal fluid levels vary from patient to patient, and fluid accumulation can be either slow or rapid, OptiVol’s ability to measure fluid status trends over time can provide important insights that are used in conjunction with ongoing monitoring of other patient symptoms.

Remote management of cardiac device patients with OptiVol who are on the Medtronic CareLink® Network is further enhanced with the company’s wireless device offerings: the Concerto® CRT-D, Virtuoso® ICDs and Vision 3D™ devices. Physicians in Europe can pre-program these devices’ CareAlerts™ signals, which are designed to give automatic notification to the physician via text message (SMS), email or a Medtronic CareLink Web site message when a patient’s individualized OptiVol threshold is crossed, without the physician having to see the patient in-office for diagnosis.

Introduced in 2002, the Medtronic CareLink Network is the leading Internet-based remote patient management system. Today, more than 275,000 patients at more than 2,500 clinics in 20 countries are followed remotely via the CareLink Network, saving patients time by eliminating in-office visits, and allowing physicians to perform a complete analysis of all the device- and patient-specific cardiac data stored within Medtronic patients’ ICDs, pacemakers and CRT devices.

About the Study Led by Dr. Landolina

Involving 532 patients at 34 Italian centers, the purpose of the study was to describe the use of intrathoracic impedance monitoring in clinical practice, and evaluate the clinical usefulness of the associated alert in reducing clinically relevant events and heart failure hospitalisations. There were 362 documented OptiVol events in 230 patients (43.2 percent of patients). Clinical events (i.e. hospitalisation, heart failure deterioration without hospitalisation, pneumonia, and others) occurred within two weeks of 47 percent of the OptiVol events. Another 20 percent of the OptiVol events were judged reliable and the drug therapy was adjusted, despite the absence of overt signs of clinical deterioration.

Additional Data

A presentation earlier in the congress, “Remote Device Monitoring and Heart Failure Management of CRT-ICD Patients,” on remote patient management for those who have Medtronic CRT-Ds equipped with the OptiVol feature revealed that 70 percent of episodes evaluated using a Medtronic CareLink transmission of device and patient data were managed remotely without requiring additional in-hospital visits by the patients.

“My experience with OptiVol and CareLink has given me options for the detection of heart failure events and treatment adjustments, with the potential to reduce both morbidity and the need for clinic or hospital visits,” said Dr. Renato P. Ricci of S. Filippo Neri Hospital in Rome, who presented the earlier data.

1 Rosamond W, et al. Heart disease and stroke statistics: 2007 update. Circulation. 2007; 115: e69–e171

Editor’s Note: “Reduction of Heart Failure Hospitalisations in Patients Implanted with a Defibrillator Equipped with an Alert System on Intrathoracic Impendence” was presented by Dr. Landolina on 1 September, and “Remote Device Monitoring and Heart Failure Management of CRT-ICD Patients” was presented by Dr. Ricci on 31 August. To arrange interviews with Drs. Landolina, Ricci or John Morgan of Southampton University, Southampton, England, please contact Tracy McNulty at 612.819.2190.

Caution: OptiVol Alerts are investigational and not currently available in the United States.

About Medtronic

Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.


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