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Medtronic obtains Japanese approval for Evera MRI ICD system

US-based Medtronic has received Japanese regulatory approval for its Evera MRI SureScan implantable cardioverter-defibrillator (ICD) system.

Officially launched in Japan, the system is said to be used for magnetic resonance imaging (MRI) scans positioned on any region of the body.

Medtronic tachycardia business vice-president and general manager Marshall Stanton said: "This means that in addition to having the highest standard in modern ICD treatment, patients implanted with an Evera MRI defibrillator will now have improved access to one of the most important diagnostic tools – the MRI.

"Compared to other ICDs available, the Evera MRI system gives patients the most unrestricted access to MRI scans, and ultimately allows them to get the diagnostic answers they need."

Featuring a contoured shape with thin and smooth edges, the Evera MRI device is available in single chamber and dual chamber ICDs.

Evera MRI is paired with the Sprint Quattro Secure family of ICD leads, and includes SmartShock 2.0 shock reduction algorithm, which allows the device to better differentiate between dangerous and harmless heart rhythms.

It also features OptiVol 2.0 Fluid Status Monitoring that helps to identify patients at risk of worsening heart failure and atrial fibrillation.

According to the company, the Evera MRI ICD is currently limited to investigational use in the US.