Japan approves Medtronic insertable cardiac monitor

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Medtronic has received Japanese regulatory approval for the Reveal DX insertable cardiac monitor (ICM)–the first insertable cardiac monitor to be introduced in Japan.

The Reveal DX ICM provides insight into syncope, which 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, according to the Minneapolis, Minn.-based Medtronic.

Inserted under the skin of the chest area, the company said its Reveal DX ICM is approximately the size of a memory stick and 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 events, according to Medtronic. 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.

Medtronic Japan will begin marketing the Reveal DX ICM once it has attained insurance reimbursement for the device. The company said it 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 U.S., Western Europe and Canada.