Medtronic Receives FDA Approval for Implantable Cardioverter Defibrillator System

Medtronic has received FDA approval for its implantable cardioverter defibrillator system for use with MRI scans.

The Evera MRI SureScan ICD System is approved for MRI scans on any part of the body without positioning restrictions. The system includes the Evera MRI ICD and Sprint Quattro Secure MRI SureScan DF4 leads, which must be used together to be considered MR-conditional.

Patients in the U.S. who depend on ICDs now have access to MRI scans if and when they need them. Until now, the FDA has advised patients with ICD not to receive MRI scans because of potential interactions between the MRI and device function, which might result in risk to patient.

The device, which will be commercially available this month, will serve an unmet need as 36 percent of patients with ICDs are likely to need an MRI, according to Medtronic. —Michael Cipriano