Irish medical technology firm Medtronic has received approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for its Reveal LINQ insertable cardiac monitor (ICM) system.
The company also secured reimbursement approval from MHLW for the Reveal LINQ ICM system.
Reveal LINQ ICM system is the insertable cardiac monitoring device that will enable physicians to rapidly and accurately diagnose irregular heartbeats.
By using minimally invasive procedure, the device will be placed underneath the skin through a small incision of less than 1cm in the upper left side of the chest.
In Japan, the physicians will use the device to diagnose unexplained syncope (unexplained fainting) and cryptogenic stroke (stroke of unknown cause).
Reveal system can automatically and continuously detect and record abnormal heart rhythms for up to three years.
The device is MR-Conditional, enabling patients to undergo magnetic resonance imaging (MRI), if required.
Reveal will also communicate wirelessly with a patient bedside monitor, which uploads device data to the Medtronic CareLink network.
The device will be available in the country beginning this month.
According to Medtronic, around 200,000 Japanese patients each year suffer from episodes of syncope and 20% to 30% of these cases are diagnosed as unexplained.
Medtronic diagnostics and monitoring business general manager and vice president Nina Goodheart said: "Medtronic is the pioneer in the miniaturization of medical devices that improve the overall experience for patients.
"We are pleased that through our collaboration with MHLW, we can now offer this minimally invasive technology for Japanese patients with syncope and cryptogenic stroke."