Medtronic (NYSE:MDT) said it won CE Mark approval in the European Union for the world’s 1st market-cleared implantable cardiac defibrillator that’s safe for full-body magnetic resonance imaging scans, its Evera MRI SureScan ICD.
The Evera device is slated for an immediate launch in Europe, according to a press release.
"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," tachycardia general manager Dr. Marshall Stanton said in prepared remarks. "An ICD that allows for full-body access to MRI will help patients get the diagnostic answers they need."
The CE Mark clears the Evera ICD for MRI scans "positioned on any region of the body," according to the release. The device also features Medtronic’s SmartShock 2.0 algorithm, designed to reduce unnecessary shocks, and can be paired with the Sprint Quattro Secure line of ICD leads, Medtronic said.
"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," Stanton added. "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."