Medtronic has secured government approval to sell resynchronization defibrillators that are safe to use with magnetic resonance imaging — the third time in five years that the Minnesota-run medical device company has scored first-to-market status for products with the sought-after feature.
The company announced Friday that the Food and Drug Administration approved its Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan devices. The prescription-only devices, used with MRI-safe lead wires, will be commercially available in coming months.
An implantable defibrillator is a device that monitors a patient's heart beat and can deliver low- or high-voltage shocks to return it to normal rhythm. A cardiac resynchronization therapy (CRT) defibrillator can deliver energy to the left and right chambers of the heart simultaneously, forcing them to beat in sync to treat heart failure.
All of the major U.S. heart-device makers have been working toward MRI compatibility because the magnetic scanning of soft tissues is relatively common in the population of people who get CRT defibrillators.
Medtronic research shows that at least 40 percent of people who get CRT defibrillators, for example, will need to have an MRI scan within four years to diagnose conditions like stroke, cancer, Alzheimer's disease and chronic pain.
Until last week, the FDA did not recommend people with CRT defibrillators undergo MRI scans because of risk to patients. Medicare does not pay for MRI scans done on people with cardiac devices not approved for use with MRI scanners, Medtronic said.
In 2011, Medtronic became the first company to get FDA approval for an MRI-safe pacemaker, known as the Revo MRI SureScan Pacemaker. Last September, the company got the OK for Evera MRI SureScan ICD, the first implantable defibrillator to get approval. With Friday's FDA action, these are the first CRT defibrillators to hit the U.S. market with MRI-safe approval.
"Medtronic continues to lead the market in MR-conditional implantable cardiac devices, bringing greater access to patients that need this vital diagnostic test to identify other potential life-threatening diseases," Medtronic cardiac rhythm medical director Dr. David Steinhaus said in a news release.
A company spokeswoman said Medtronic is evaluating other devices that could benefit from being MRI safe. She noted that Medtronic's Reveal Linq cardiac monitor is MRI-approved, as is the Activa deep-brain stimulation device for Parkinson's disease and the RestoreSensor spinal cord stimulator for chronic pain.
St. Jude Medical and Boston Scientific, both of which sell competing pacemakers and implantable defibrillators, lost market share to Medtronic after the release of the Evera MRI ICD.
St. Jude reported an 11 percent decline in ICD sales in its quarter that ended Jan. 2, and Boston Scientific reported a 7 percent ICD sales drop for the quarter that ended Dec. 31. The CEOs of both companies told investors recently that they expect FDA clearances of some MRI-safe heart devices later this year, and in 2017.