FDA OKs Medtronic’s MRI-compatible heart failure devices

Medtronic HQ

Medtronic bagged FDA approval for its line of MRI-compatible cardiac rhythm and heart failure devices, allowing patients with devices such as pacemakers and implantable defibrillators to undergo MRI scans on any part of their body.

Each year, about 12% to 16% of patients with cardiac devices have a condition for which an MRI would be carried out, but less than 1% of this group received imaging because of possible interaction between the device and the MRI, Medtronic said in a statement.

Under the approval, patients with Medtronic SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators and leads can receive imaging in 3- and 1.5-Tesla MRI machines, according to the statement. MRI is used to diagnose a range of conditions, ranging from stroke and cancer to Alzheimer’s disease.


Join the world's top medtech executives virtually for the leading event in medtech — The Virtual MedTech Conference by AdvaMed

Expect the same high-quality education, world-class speakers and valuable business development in a virtual format. Experience more of the conference with on demand content and partnering, as well as livestreamed sessions.

While 1.5-Tesla MRI machines still dominate in the U.S., 3-Tesla scanners are expected to reach between 30% and 40% of U.S. hospitals over the next five years, according to the statement.  "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,” said Dr. Yair Safriel, a neuroradiologist at Pharmascan Clinical Trials and the University of South Florida, in the statement.

"The potential interaction between cardiac devices and MRIs has been a long-running concern for patients and physicians," said Dr. Marc Silver, a cardiologist at WakeMed Heart and Vascular Physicians in Raleigh, in the statement. "Fortunately, advancements in MR-conditional cardiac device technology give patients more access to this important diagnostic tool."

Suggested Articles

Chi-Med has detailed plans to seek approval from the FDA later this year in part on the strength of data from Chinese phase 3 trial.

Takeda tapped Roche’s Foundation Medicine to develop tissue- and blood-based companion diagnostic tests for its portfolio of lung cancer therapies.

The clamor for more transparency from the leading pandemic vaccine contenders has been getting louder.