Healthcare Industry News:  cardiac monitor 

Devices Cardiology Regulatory

 News Release - July 9, 2007

Medtronic Insertable Heart Monitor Gives New Insight into Heart Rhythm Disorder

European Patients First to Have Access to Long-Term, Continuous Monitoring of Atrial Fibrillation

MINNEAPOLIS & ARNHEM, The Netherlands--(HSMN NewsFeed)--Today Medtronic, Inc. (NYSE:MDT ) announced the European introduction of RevealŪ XT, the first Insertable cardiac monitor that offers long-term and continuous monitoring of Atrial Fibrillation (AF). All other current monitoring tools are either for a limited period or on an intermittent basis. Long-term, continuous monitoring means that a clinician no longer needs to rely only on incomplete data to evaluate how AF may be progressing or treatment effectiveness. The device recently received CE (Conformite Europeenne) Mark, and the first implant of Reveal XT took place at Asklepios Klinik St. Georg in Hamburg, Germany by Prof. Karl-Heinz Kuck, M.D. The Reveal XT insertable cardiac monitor is not currently available for sale in the United States.

AF is the most common cardiac arrhythmia, experienced by 4.5 million patients in Europe(1). Treatment of AF is difficult as episodes often show no symptoms and therefore go unnoticed by patients(2). Yet the risks are well known - AF can lead to a two to seven times higher risk of stroke(1), an increased risk of heart failure and sudden cardiac death(3) due to inefficient pumping in the heart.

"Atrial fibrillation is the most frequent cardiac arrhythmia. It is often accompanied by symptoms that are very unpleasant for the patient," said Prof. Kuck, Hanseatisches Herzzentrum / Department of Cardiology, Asklepios Klinik St. Georg. "Moreover, atrial fibrillation is linked with increased mortality and an increase in the incidence of stroke, by a factor of two- to seven-fold. However, with the new Reveal XT, atrial fibrillation can now be scrutinized over a period of three years with a subcutaneous monitor. This gives us totally new possibilities for monitoring and adjusting the treatment."

The Only Way of Precisely Treating AF Is Knowing AF

The Reveal XT Insertable cardiac monitor monitors AF patients 24 hours a day, every day for up to three years. There are a variety of ways to treat AF, but up until now physicians had no means of gathering detailed data, over an extended period, on the progression of AF and the effect of treatment. Reveal XT gives new insight into patients' heart rhythms, which may help physicians to evaluate stroke risk and determine appropriate treatment and therapy options for their patients.

24/7 Monitoring Provides Patient Compliance

As Reveal XT is inserted just under the skin, the patient experiences no restrictions in daily activities. This is not only more comfortable for the patient, but also ensures that cardiac data recorded is not influenced by restrictions in activities. Patients continue to lead their normal life and therefore heart activity recorded shows real-life, relevant information. Once patients leave the clinic, Reveal XT does not require wires or sticky pads to monitor the patients' heart rhythms.

(1) ACC/AHA/ESC Guidelines for the Management of Patients with Atrial Fibrillation

(2) T. Fetsch, EHJ. 2004;1385-1394

(3) A. Krahn et al. Am J Med. 1995; 98:476-484

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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