Medtronic Receives FDA Clearance for MRI-Safe Pacemaker Devices
The U.S. Food and Drug Administration cleared a portfolio of cardio resynchronization therapy-pacemakers (CRT-Ps) made by Medtronic, all of which offer a key functionality: the ability to undergo magnetic resonance imaging, or MRI scans.
The safety of performing MRI scans on a patient with an implanted pacemaker is an issue that has been debated for years. Past studies, according to a report by Medscape, have found that MRI scanning of a heart with a pacemaker has led to tissue damage and, in other cases, death.
Medtronic’s line of quadripolar CRT-Ps, however, were deemed safe on Wednesday for use in either 1.5 or 3 Tesla scanners.
The pacemakers, which include the company’s Percepta, Serena and Solara model Quad CRT-P SureScan devices, are expected to be available commercially in the U.S. this summer.
“With FDA approval of these quadripolar CRT-P devices, we can offer the most innovative pacing technology for improved patient outcomes and enhanced design for their comfort,” said David Steinhaus, vice president and general manager of Medtronic’s heart failure business, in a statement.
Several months ago, in February, Medtronic’s CRT-P portfolio also received CE Mark approval, which will allow it to sell the devices in Europe as well.
Although incorporated in Ireland, Medtronic is one of Minnesota’s largest employers as its operations management runs out of Fridley. Of its 88,000 employees worldwide, about 10,000 are located in Minnesota.
Medtronic is the world’s largest medical technology company with fiscal year 2016 sales of nearly $29 billion. The company announced this week it would report its fiscal year 2017 results on May 25.