Medtronic has received FDA clearance for its Revo MRI SureScan pacing system, the first and only pacemaker in the U.S. specifically designed for use in an magnetic resonance imaging environment.
About half of all patients with pacemakers may require an MRI. However, they are advised not to have one because an MRI's magnetic and radiofrequency fields can disrupt the pacemaker's setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure or tissue damage.
But the Revo system includes a function that is turned on before a scan to prepare patients for the MRI. The pacemaker's use in MRIs is limited to certain patients and specific areas of the body. The FDA also is requiring training for cardiologists and radiologists who use the system.
"FDA's approval of the Revo pacemaker represents an important step forward toward greater device innovation," said CDRH Director Jeffrey Shuren. "Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI."
"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," adds J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville.
The company had hoped to launch the Revo product last year, but an FDA warning letter held up approval, as the Pioneer Press notes. Shipments of Revo MRI will begin immediately, according to a Medtronic statement.
- get the Medtronic release
- read the FDA's statement
- check out more from the Pioneer Press