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Medtronic obtains CE Mark approval for Evera MRI SureScan ICD system

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

Medtronic claims that the contoured shape of the new Evera MRI ICD system with thin, smooth edges makes the device to better fit inside the body, increasing patient comfort by reducing skin pressure by 30%. The Evera MRI ICD system is paired with the Sprint Quattro secure family of ICD leads.

The new device incorporates SmartShock 2.0, OptiVol 2.0 fluid status monitoring and complete diagnostics. It has battery longevity of approximately 11 years.

SmartShock 2.0, a shock reduction algorithm, 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.

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 noted 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.

"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." Dr Stanton added.