July 15, 2008 - Medtronic Inc. today received Japanese regulatory approval for the Reveal DX Insertable Cardiac Monitor (ICM), which was 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. The company said the device automatically records and saves arrhythmias, 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 Reveal DX ICM is also commercially available in the United States, Western Europe and Canada.
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).
For more information: www.medtronic.com