09.05.2006 12:00:00

Medtronic Begins Landmark Clinical Trial: Cardiac Device Combines Defibrillation and Heart Monitoring; Heart-Failure Device Demonstrates Medtronic's Focus on Cardiac Disease Management

Medtronic, Inc. (NYSE:MDT) today announced the launch ofa landmark clinical trial for a new heart-failure device that combinesthe capabilities of an implantable cardioverter defibrillator (ICD)with a new technology that continuously records pressure inside theheart, and can alert physicians to potential heart-failurecomplications before they worsen.

The investigational device, known as the Chronicle(R) ICD,features both the traditional ICD's ability to restore normal heartrhythm following a dangerously fast heartbeat and the first-everreal-time tracking of pressure inside the heart, body temperature,patient activity and heart rate 24 hours a day. Patients implantedwith a Chronicle ICD will transmit that information from home, using astandard phone line, to their physicians who view the recorded datafrom a secure Web site in their office and then potentially makechanges to patients' medications or diet.

"Chronicle ICD represents a fundamental change in the wayheart-device makers and cardiologists will address chronic diseasessuch as heart failure in the years to come," said the clinical trial'sprincipal investigator, Philip B. Adamson, M.D., Director, The HeartFailure Institute at Oklahoma Heart Hospital, Oklahoma City. "It's nolonger enough to wait until patients develop symptoms of worseningheart-failure - patients and physicians need technology, likeChronicle ICD, that has the potential to provide an early and accurateindication of deterioration in heart failure status, thereby allowingclinicians to take appropriate preventive measures."

The study seeks to determine the safety, efficacy andfunctionality of the Chronicle ICD when used in heart-failure patientsindicated for ICD therapy. Sponsored by Medtronic, the blinded studyis a prospective, randomized, multi-center clinical trial at up to 75sites in the United States involving approximately 850 patients withmild to moderate heart failure (NYHA Class II and III). Heart failureis a condition in which the heart pumps blood inadequately, leading toreduced blood flow and possible back-up of blood in the veins andlungs. Heart failure can lead to sudden cardiac arrest (SCA), anabrupt loss of heart function caused by a rapid, chaotic disturbanceof the heart's natural rhythm that is almost always fatal withoutdefibrillation.

"Chronicle ICD expands the walls of the cardiologist's office"said Eugene Chung, M.D., of the Ohio Heart & Vascular Center and leadinvestigator for Christ Hospital in Cincinnati, site of the firstimplant in the Chronicle ICD study. "By continuously recordingpressure inside the heart, Chronicle ICD provides heart failureclinicians with a precise and early assessment of the patient'sunderlying congestion, allowing for immediate treatment changes basedon the patient's most up-to-date data. This is data previously onlyavailable through invasive testing in a cath lab or ICU. Neither thepatient nor the doctor has to wait for the next office visit."

Focusing on Cardiac Disease Management

Chronicle ICD represents Medtronic's commitment to and leadershipin developing medical technology that helps physicians and theirpatients better manage heart disease and heart-rhythm conditions andprevent complications from developing - potentially decreasingphysician office visits, trips to the emergency room, andhospitalizations as a result of worsening heart failure.

"The next generation of heart-device technology will not onlyrespond to heart-rhythm anomalies when they occur but also provideclinicians with critical data and insight into the patient'sunderlying condition to improve the overall management of cardiacdisease," said Steve Mahle, president of Medtronic Cardiac RhythmManagement. "As Medtronic has been since it invented the pacemaker, weare proud to be on the forefront of this exciting new chapter in theevolution of medical technology."

In addition to Chronicle ICD, Medtronic has pioneered severalcardiac rhythm and disease management technologies, bothinvestigational and FDA approved, which monitor patients' heartfunctions and allow cardiologists to make immediate care decisionsbased on this information. Some of Medtronic's pioneering devicesinclude the following:

-- Concerto(TM) AT Cardiac Resynchronization Therapy-Defibrillator. Medtronic's Concerto(TM) 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(TM) 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(R) 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(R) 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, and550,000 new cases are diagnosed annually. The estimated direct andindirect cost of heart failure in 2004 was $25.8 billion, two thirdsof which is due to hospitalization and home nursing care. Every yearmore than 1 million hospitalizations occur due to acute heart failureexacerbation, and it is estimated that approximately half of these areattributed to about 200,000 patients who are admitted at least twiceper year. These patients may benefit greatly from more intense careand specialized follow up to prevent repeated hospital admissions.

Caution: The Chronicle ICD is an investigational device. Thedevice is limited by federal (or United States) law to investigationaluse 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 theworld.

Any forward-looking statements are subject to risks anduncertainties such as those described in Medtronic's Quarterly Reporton Form 10-Q for the quarter ended January 27, 2006. Actual resultsmay differ materially from anticipated results.

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