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News

Medtronic's Reveal DX ;INSERTable Cardiac Monitor receives Japanese regulatory approval

Medtronic : 15 July, 2008  (New Product)
Medtronic 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. The 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 USA, Western Europe and Canada.
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