Healthcare Industry News:  Parkinson's disease 

Devices Cardiology Monitoring Regulatory

 News Release - July 15, 2008

Medtronic Launches First Insertable Cardiac Monitor in Japan

Reveal DX ICM Offers Insights For Unexplained Fainting

MINNEAPOLIS & TOKYO--(HSMN NewsFeed)--Medtronic, Inc. (NYSE: MDT ) today announced it has received Japanese regulatory approval for the Reveal DX™ Insertable Cardiac Monitor (ICM). The device has been designated by the Japanese government as a high-priority medical device, and is the first insertable cardiac monitor to be introduced in Japan.

The Reveal DX ICM provides insight into unexplained fainting episodes, also known as syncope. Syncope is difficult to diagnose as episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques such as ECG Holter monitors or external loop recorders. These tests are limited to 24 hours and one month, respectively; combined with the constraints placed on the patient’s daily life and the limited likelihood of an event occurring during the monitoring period, the testing may fail to determine the cause of the episodes.

Inserted just under the skin of the chest area, the Reveal DX ICM is approximately the size of a memory stick; it is capable of monitoring patients for up to three years, allowing for long-term, continuous cardiac monitoring. Records of arrhythmias are automatically recorded and saved, and patients may prompt the device to record any events at any time. If the patient experiences a syncopal episode, the information collected by the device may help the physician determine if the episode is attributable to an arrhythmia.

Since no similar device has been available in Japan, the Ministry of Health, Labor and Welfare designated the Reveal DX as “high priority” for approval in Japan. The device was subject to a fast-track evaluation by the Japanese government, and received regulatory approval in July 2008.

Medtronic Japan will begin marketing the Reveal DX ICM once it has attained insurance reimbursement for the device. The company will partner with Asahi Kasei for exclusive sales distribution rights for the device in Japan; Medtronic Japan will serve as the device’s designated Marketing Authorization Holder.

The Reveal DX ICM is also commercially available in the United States, Western Europe and Canada.

About Syncope

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. Approximately 1.5 million people worldwide suffer from unexplained syncope. In almost 10 percent of patients, syncope has a cardiac cause (in 50 percent of cases, the cause is non-cardiac; and in 40 percent of cases the cause is unknown1).

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

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, alleviating pain, restoring health and extending life for people with chronic disease. Its Internet address is www.medtronic.com.

About Medtronic Japan

Medtronic therapies cover a wide range of afflictions, from cardiac diseases to Parkinson's disease, diabetes, spinal disorders, cerebral disorders, chronic pain other chronic conditions. Medtronic Japan was founded in 1975 and has spent more than 30 years alleviating pain and restoring life for Japanese patients suffering from chronic diseases. Web site: http://www.medtronic.co.jp

About Asahi Kasei

Asahi Kasei provides innovative solutions based in chemistry and materials science to a diverse range of markets including fibers, chemicals, consumer products, housing, construction, electronics, and health care. Web site: http://www.asahi-kasei.co.jp/asahi/jp/index.html

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.


Source: Medtronic

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