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April 10, 2014

Medtronic’s Evera MRI SureScan ICD system gets CE Mark

Medtronic has obtained CE Mark approval for its Evera MRI SureScan, an implantable cardioverter-defibrillator (ICD) system designed to allow for full-body MRI scans positioned on any region of the body.

By Mekala ShivaramPrasad

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Medtronic has obtained CE Mark approval for its Evera MRI SureScan, an implantable cardioverter-defibrillator (ICD) system designed to allow for full-body MRI scans positioned on any region of the body.

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The company has also announced the launch of its Evera MRI ICD system in Europe. The new ICD system is not yet approved in the US.

Featuring a contoured shape with thin, smooth edges, the new Evera MRI ICD system better fits inside the body and increases patient comfort by reducing skin pressure by 30%. Compared with previous devices, the new system has battery longevity of up to 11 years.

Medtronic’s Evera MRI ICD system is paired with the Sprint Quattro secure family of ICD leads. The device incorporates SmartShock 2.0, OptiVol 2.0 fluid status monitoring and complete diagnostics.

"Patients suffering from debilitating heart rhythm disorders who need an ICD also are likely to need an MRI over the lifetime of their device and this technology allows them to do so."

SmartShock 2.0 is a shock reduction algorithm, which enables the ICD to better differentiate between dangerous and harmless heart rhythms. It helps to eliminate the inappropriate shocks, and delivers a 98% inappropriate shock free rate at one year.

In addition, OptiVol 2.0 fluid status monitoring and complete diagnostics help to identify patients at risk of worsening heart failure and atrial fibrillation.

Medtronic vice-president and tachycardia business general manager Dr Marshall Stanton said: "An ICD that allows for full-body access to MRI will help patients get the diagnostic answers they need.

"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.

"Patients suffering from debilitating heart rhythm disorders who need an ICD also are likely to need an MRI over the lifetime of their device and this technology allows them to do so."


Image: Medtronic’s world headquarters in Minneapolis, US. Photo: courtesy of Medtronic Inc.

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  • Medical device pricing data that can be tracked by market, company, and brand
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