The Evera SureScan device is the 1st to be the subject of a U.S. trial for an ICD that’s safe for full-body MRI scans, Medtronic said. The device won CE Mark approval in the European Union earlier this month.
The 1st patient in the 275-subject study was implanted with the Evera SureScan device at Marquette General Hospital in Marquette, Mich., by Dr. Mark Cowan. 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, according to a press release.
"Our goal with the Evera MRI system is to give patients the most unrestricted access to MRI scans, and ultimately allow them to get the diagnostic answers they need," tachycardia general manager Dr. Marshall Stanton said in prepared remarks. "Medtronic has been a leader in developing implantable devices that are safe for the MRI environment, and we believe ICDs will be no exception in the near future."
Medtronic said April 9 that it plans an immediate launch for the Evera SureScan in Europe under its new CE Mark approval.