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First Implantable Cardioverter-Defibrillator System to Allow for Full-Body MRI Scans Launched

By Medimaging International staff writers
Posted on 01 May 2014
Image: The Evera MRI SureScan implantable cardioverter-defibrillator (ICD), shown with leads (Photo courtesy of Medtronic).
Image: The Evera MRI SureScan implantable cardioverter-defibrillator (ICD), shown with leads (Photo courtesy of Medtronic).
A new implantable cardioverter-defibrillator (ICD) system is the first to combine effective treatment performance, improved comfort, increased longevity, with full-body magnetic resonance imaging (MRI) access.

Medtronic (Minneapolis, MN, USA) announced the CE (Conformité Européenne) marking along with the European launch of the Evera MRI SureScan ICD system, the first and only ICD system approved for magnetic resonance imaging (MRI) scans positioned on any region of the body. The Medtronic Evera MRI ICD is not approved in the United States.

It is estimated that as many as 63% of ICD patients will need an MRI within 10 years of receiving a device. Until the availability of MR-Conditional ICD systems, patients with devices have been contraindicated from receiving MRI scans because of potential interactions between the MRI and device function.

“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,” said Marshall Stanton, MD, vice president and general manager of the tachycardia business at Medtronic. “An ICD that allows for full-body access to MRI will help patients get the diagnostic answers they need.”

Like its non-MR-Conditional predecessor, the Evera MRI features a contoured shape with thin, smooth edges that better fits inside the body, increasing patient comfort by reducing skin pressure by 30%.The Evera MRI maintains the same industry-leading battery longevity (up to 11 years) compared to previous devices. Furthermore, Evera MRI is paired with the Sprint Quattro Secure range of ICD leads, which has 10 years of established performance with active monitoring and is safe for use in an MRI setting.

Evera MRI includes SmartShock 2.0, a shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms. Whereas most of shocks delivered are necessary to treat potentially fatal arrhythmias, studies estimate that approximately 20% of patients with implantable defibrillators may experience inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device. SmartShock technology helps to eliminate these inappropriate shocks, and delivers a 98% inappropriate shock-free rate at one year. Also included in the Evera MRI is OptiVol 2.0 fluid status monitoring and complete diagnostics, which helps to identify patients at risk of worsening heart failure and atrial fibrillation.

“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,” said Dr. Stanton. “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.”

The Evera MRI system is the latest addition to a growing number of Medtronic devices that are designed for MRI access including the Medtronic SureScan pacing systems, neurostimulation systems for the management of chronic pain and the SynchroMed II programmable drug infusion system.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic provides a wide range of medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

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