FDA approves first and only MRI-safe pacemaker
Medtronic's Revo MRI SureScan is designed for use during magnetic resonance imaging. The company says it will begin shipping the $5,000 to $10,000 devices immediately.
Pacemaker patients who opt for magnetic resonance imaging risk serious complications, including damage to the pacemaker's parts or a change in the device's ability to consistently trigger a heartbeat (called pacing capture threshold). That is, until now.
The U.S. Food and Drug Administration has just approved Medtronic's Revo MRI SureScan pacemaker for use in the U.S.; in doing so, the SureScan has become the first and only pacemaker in the country approved as MR-Conditional.
Minneapolis-based Medtronic says it will begin shipping the pacing system--which costs between $5,000 and $10,000--immediately.
"[This] is a major technological breakthrough for patients who need access to MRI," says Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville, Tenn., in a news release. "Providing pacemaker patients with access to MRI allows detection and treatment of serious medical conditions such as stroke, cancer, and a wide variety of important neurologic and orthopedic conditions."
Because MRI scanners can cause pacemakers to misinterpret MRI-generated electrical noise and withhold (or delivery unnecessary) pacing therapy, the Revo includes "SureScan" technology that sets the device into MRI mode, with hardware modifications to both the device and the leads that reduce hazards produced by MRIs.
Since Medtronic's pacemakers are designed "to treat bradycardia (a slow, irregular, or interrupted heartbeat)," pacemaker patients tend to be a population that could benefit from MRI scans. Medtronic estimates that some 200,000 pacemaker patients in the U.S. who could use MRI scans for a variety of diagnoses forgo them due to the risks of pacemaker interference and complications.
In 2009, the FDA alerted pacemaker patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers, which were found to at times fail due to a separation of wires connecting the electronic circuit to certain parts, including the battery. These pacemakers are no longer for sale.