Medtronic (NYSE:MDT) said it won approval from Japan’s Ministry of Health, Labor and Welfare for its Evera MRI SureScan implantable cardiac defibrillator for use in full-body MRI scans.
The approval also includes a nod for reimbursement, 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 1 of the most important diagnostic tools – the MRI," tachycardia business general manager Dr. Marshall Stanton said in prepared remarks. "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."
The Evera MRI SureScan won CE Mark approval in the European Union in April. Later that month Medtronic launched a 275-subject investigational device exemption trial in the U.S.
The device 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.