Medtronic has gained CE Mark approval for its Evera MRI™ SureScan® implantable cardioverter-defibrillator (ICD) System. The company says this is the first and only ICD system approved for magnetic resonance imaging (MRI) scans positioned on any region of the body.
MRI compatibility is the next big thing in implantable heart devices, this capability having been identified as growth driver over the next few years. A couple of weeks ago we were writing about Biotronik’s U.S. trial expansion of its Iforia, MRI-compatible ICD to look at its use with an MRI exclusion zone. Find that piece here.
It is estimated that as many as 63 percent of ICD patients will need an MRI within 10 years of receiving a device, diagnostic tool hitherto not available for patients with these devices because of potential interactions between the MRI and device function.
The Evera MRI system is the latest addition to a growing number of Medtronic devices which 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.
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 percent according to company data. The Evera MRI maintains the same industry-leading battery longevity (up to 11 years) compared to previous devices.
Evera MRI is paired with the Sprint Quattro® Secure family of ICD leads, which has 10 years of proven performance with active monitoring and is also safe for use in an MRI environment.
Evera MRI includes SmartShock™ 2.0 – an exclusive shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms, so avoiding delivery of inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device. 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.
The Medtronic Evera MRI ICD will now see its European launch, but remains unapproved in the United States.
“…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, M.D., 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.”
“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 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.”
Source: Medtronic, Inc.