Healthcare Industry News:  cardiac monitor 

Devices Cardiology Regulatory

 News Release - July 9, 2007

New Medtronic Implantable Cardiac Monitor Gives Physicians Valuable Insights into the Cause of Unexplained Fainting

Reveal(R) DX Monitors the Heart for Up to Three Years

MINNEAPOLIS & ARNHEM, The Netherlands--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) today announced the European introduction of the RevealŪ DX, a new Insertable cardiac monitor that offers diagnostic and monitoring information related to syncope (fainting) in patients. The device recently received CE (Conformite Europeenne) Mark, and the first implant of Reveal DX took place at Ospedali del Tigullio in Lavagna, Italy, by Prof. Michele Brignole, M.D. Placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure, the monitor records important data before, during and after a syncopal event. This data enables the physician to diagnose the patient and determine the right treatment based on long-term cardiac rhythm trend data. The Reveal DX insertable cardiac monitor is not currently available for sale in the United States.

Approximately 1.5 million people worldwide suffer from unexplained syncope. In almost 10 percent of patients, syncope has a cardiac cause; in 50 percent, a non-cardiac cause; and in 40 percent of patients the cause of syncope is unknown(1). It is a leading cause of emergency room visits. Syncope is difficult to diagnose as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques.

With the information obtained from the Reveal DX, the physician can understand if the cause of syncope is cardiac related, which may help to appropriately manage the patient's arrhythmia.

"Syncope can cause a considerable degree of anxiety and activity restrictions for people," said Prof. Brignole of the Department of Cardiology, Ospedali del Tigullio. "Application of this insertable cardiac monitor helps me to diagnose the underlying cause of syncope so that I can treat my patients appropriately."

Always on Watch

The Reveal DX continuously monitors the heart's electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. Reveal DX is the only insertable cardiac monitor that can record an ECG at the time of a syncopal episode.

(1)E.S. Soteriades et al. N Eng J Med. 2002; 347 (12):878-885

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.

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 27, 2007. Actual results may differ materially from anticipated results.


Source: Medtronic

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