Medtronic gets FDA approval for MRI compatible cardiac rhythm and heart failure devices



Medtronic has announced US Food and Drug Administration (FDA) approval for its suite of cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla (T) magnetic resonance imaging (MRI) machines.

This advancement gives patients with Medtronic SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronisation therapy-defibrillators (CRT-Ds) and leads access to MRI scans on any part of the body.

Each year, approximately 12-16% of patients with cardiac devices have a condition in which MRI would normally be prescribed, but less than 1% 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.

“The potential interaction between cardiac devices and MRIs has been a long-running concern for patients and physicians,” says Marc Silver (WakeMed Heart and Vascular Physicians, Raleigh, USA). “Fortunately, advancements in MR-conditional cardiac device technology give patients more access to this important diagnostic tool.”

“While 1.5T scanners still comprise the majority of installations, 3T scanners are expected to comprise more than half of new units—with some centres having only 3T scanners—since they offer faster scans and higher resolution images,” says Yair Safriel, neuroradiologist and chief medical officer at Pharmascan Clinical Trials and University of South Florida, USA. “Approval for MRI conditional scanning at both 1.5 and 3T allows patients to have improved access to MRI at a time and place most appropriate for their care. And with 3T scanning, physicians and radiologists gain a clearer look into soft tissues, particularly critical when diagnosing serious conditions, often involving the brain and spine.”

Patients in the USA with the following devices are now eligible for 1.5 and 3T MRI scans:

  • Advisa MRI pacemakers and Micra Transcatheter Pacemaker
  • Amplia MRIand Compia MRI (CRT-D)
  • Evera MRI and Visia AF MRI DF-1 and DF4 ICDs
  • Reveal LINQ insertable cardiac monitor
  • SureScan Pacing, defibrillation and left-heart leads