FDA approves Medtronic cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla magnetic resonance imaging (MRI) machines.

Medtronic plc is the first company to receive FDA approval for its suite of cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla magnetic resonance imaging (MRI) machines. This advancement gives patients with Medtronic SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) and leads access to MRI scans on any part of the body. Each year, approximately 12-16 percent of patients with cardiac devices have a condition in which MRI would normally be prescribed, but less than 1 percent receive a scan because of device or lead restrictions. Before the availability of MR-conditional technology, patients with cardiac devices were contraindicated from undergoing MRI scans to avoid a potential interaction between the MRI and the device function.

MRI is an important imaging technology to diagnose conditions such as stroke, cancer, Alzheimer's disease, and muscle, bone and joint pain. 3T MRI offers better image quality, better diagnosis and reduced scan duration compared to 1.5T scans. In the next five years, the adoption of 3T MR systems is expected to reach approximately 30-40 percent of hospitals across the U.S.

Patients in the U.S. with the following devices are now eligible for 1.5 and 3T MRI scans: Advisa MRI Pacemakers and Micra Transcatheter Pacemaker. Amplia MRI and Compia MRI Cardiac Resynchronization Therapy Defibrillators. Evera MRI and Visia AF MRI DF-1 and DF4 Implantable Cardioverter Defibrillators.Reveal LINQ Insertable Cardiac Monitor. SureScan Pacing, Defibrillation and Left-Heart Leads.