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Medtronic Begins Landmark Clinical Trial: Cardiac Device Combines Defibrillation And Heart Monitoring

09 May 2006

MINNEAPOLIS, IN, USA | May 09, 2006 | Medtronic, Inc. (NYSE: MDT) today announced the launch of a landmark clinical trial for a

new heart-failure device that combines the capabilities of an implantable cardioverter defibrillator (ICD) with a new technology that continuously records pressure inside the heart, and can alert physicians to potential heart-failure complications before they worsen.

The investigational device, known as the Chronicle® ICD, features both the traditional ICD’s ability to restore normal heart rhythm following a dangerously fast heartbeat and the first-ever real-time tracking of pressure inside the heart, body temperature, patient activity and heart rate 24 hours a day. Patients implanted with a Chronicle ICD will transmit that information from home, using a standard phone line, to their physicians who view the recorded data from a secure Web site in their office and then potentially make changes to patients’ medications or diet.

“Chronicle ICD represents a fundamental change in the way heart-device makers and cardiologists will address chronic diseases such as heart failure in the years to come,” said the clinical trial’s principal investigator, Philip B. Adamson, M.D., Director, The Heart Failure Institute at Oklahoma Heart Hospital, Oklahoma City. “It’s no longer enough to wait until patients develop symptoms of worsening heart-failure – patients and physicians need technology, like Chronicle ICD, that has the potential to provide an early and accurate indication of deterioration in heart failure status, thereby allowing clinicians to take appropriate preventive measures.”

The study seeks to determine the safety, efficacy and functionality of the Chronicle ICD when used in heart-failure patients indicated for ICD therapy. Sponsored by Medtronic, the blinded study is a prospective, randomized, multi-center clinical trial at up to 75 sites in the United States involving approximately 850 patients with mild to moderate heart failure (NYHA Class II and III). Heart failure is a condition in which the heart pumps blood inadequately, leading to reduced blood flow and possible back-up of blood in the veins and lungs. Heart failure can lead to sudden cardiac arrest (SCA), an abrupt loss of heart function caused by a rapid, chaotic disturbance of the heart’s natural rhythm that is almost always fatal without defibrillation.

“Chronicle ICD expands the walls of the cardiologist’s office” said Eugene Chung, M.D., of the Ohio Heart & Vascular Center and lead investigator for Christ Hospital in Cincinnati, site of the first implant in the Chronicle ICD study. “By continuously recording pressure inside the heart, Chronicle ICD provides heart failure clinicians with a precise and early assessment of the patient’s underlying congestion, allowing for immediate treatment changes based on the patient’s most up-to-date data. This is data previously only available through invasive testing in a cath lab or ICU. Neither the patient nor the doctor has to wait for the next office visit.”

Focusing on Cardiac Disease Management
Chronicle ICD represents Medtronic’s commitment to and leadership in developing medical technology that helps physicians and their patients better manage heart disease and heart-rhythm conditions and prevent complications from developing – potentially decreasing physician office visits, trips to the emergency room, and hospitalizations as a result of worsening heart failure.

“The next generation of heart-device technology will not only respond to heart-rhythm anomalies when they occur but also provide clinicians with critical data and insight into the patient’s underlying condition to improve the overall management of cardiac disease,” said Steve Mahle, president of Medtronic Cardiac Rhythm Management. “As Medtronic has been since it invented the pacemaker, we are proud to be on the forefront of this exciting new chapter in the evolution of medical technology.”

In addition to Chronicle ICD, Medtronic has pioneered several cardiac rhythm and disease management technologies, both investigational and FDA approved, which monitor patients’ heart functions and allow cardiologists to make immediate care decisions based on this information. Some of Medtronic’s pioneering devices include the following:
• Concerto™ AT Cardiac Resynchronization Therapy-Defibrillator. Medtronic’s Concerto™ CRT-D with Atrial Therapies (AT) is an investigational heart-failure management device designed to automatically and wirelessly delivers information from a patient’s device to the physician’s office.
• OptiVol™ Fluid Status Monitoring. Available in select Medtronic CRT-D devices, this diagnostic feature helps manage and detect worsening heart failure by measuring the pulmonary fluid build-up in the thoracic (lungs and heart) cavity.
• Reveal® Insertable Loop Recorder. The world’s only implantable cardiac monitor that captures and stores the heart’s rate and rhythm to determine if fainting, dizziness, palpitations or unexplained seizure-like episodes are related to a heart-rhythm problem.
• Medtronic CareLink® Network. An Internet-based heart-monitoring system that enables patients with implantable devices to transmit data from their device, while at home or traveling, to their physician using a portable monitor that is connected to a standard telephone line.

More than five million Americans suffer from heart failure, and 550,000 new cases are diagnosed annually. The estimated direct and indirect cost of heart failure in 2004 was $25.8 billion, two thirds of which is due to hospitalization and home nursing care. Every year more than 1 million hospitalizations occur due to acute heart failure exacerbation, and it is estimated that approximately half of these are attributed to about 200,000 patients who are admitted at least twice per year. These patients may benefit greatly from more intense care and specialized follow up to prevent repeated hospital admissions.

Caution: The Chronicle ICD is an investigational device. The device is limited by federal
(or United States) law to investigational use only. It is not available for sale in the United States.

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

SOURCE: Medtronic, Inc

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