Medtronic has received approval from the US Food and Drug Administration (FDA) for its suite of cardiac rhythm and heart failure devices and leads to scan in both 3 and 1.5 Tesla (T) magnetic resonance imaging (MRI) machines.
Patients can now access Medtronic SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds).
The approval also leads access to MRI scans on any part of the body.
MRI imaging technology helps to diagnose conditions such as stroke, cancer, Alzheimer's disease, and muscle, bone and joint pain.
The devices that are eligible for 1.5 and 3T MRI scans include Advisa MRI pacemakers and Micra transcatheter pacemaker, as well as Amplia MRI and Compia MRI cardiac resynchronization therapy defibrillators.
Other eligible devices comprise of Evera MRI and Visia AF MRI DF-1 and DF4 implantable cardioverter defibrillators, Reveal LINQ insertable cardiac monitor, and SureScan pacing, defibrillation and left-heart leads.
According to the company, the 3T MRI offers enhanced image quality, better diagnosis and reduced scan duration compared to 1.5T scans.
Medtronic heart failure business general manager and vice president Dr David Steinhaus said: "Our goal is to help patients get the cardiac device therapy they need while ensuring they also retain access to other needed tools, such as diagnostic MRI.
“We are proud to be the first and only company to offer a comprehensive suite of MR-conditional devices and leads in the US."
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.