MRI Safe Pacemaker Wins Approval From FDA
The first pacemaker safe for MRI use was approved Tuesday by the U.S. Food and Drug Administration (FDA).
This is a much anticipated technological breakthrough that will now allow for patients with implanted cardiac devices to receive timely and essential diagnostics with an MRI.
Until now, the use of magnetic resonance imaging (MRI) exams have been contraindicated in patients who have surgically implanted pacemakers to regulate their heart beats. This type of scan uses a powerful magnetic field in conjunction with radio frequency to create 3D images of the inside of the body. It's powerful mechanisms can cause a disruption in pacemaker settings, damage to surrounding tissues, system malfunction and device failure.
There are approximately 5 million patients worldwide with pacemakers of which 50 to 75 percent will need MRIs in their lifetimes. Unfortunately, until now these patients have been advised against these scan despite necessity. MRIs are used for the detection of numerous medical conditions such as cancer, stroke and soft tissue damage. It creates a high-quality image with harmless radio and magnetic field technology, as opposed radiation-based diagnostic alternatives such as CT and X-ray.
The new FDA approved device created by Medtronic is called the Revo MRI SureScan. This surgically implanted device features a safety mechanism which, when activated, readjusts the settings of the pacemaker and protects it while in an MRI environment.
“FDA’s approval of the Revo pacemaker represents an important step forward toward greater device innovation,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “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.”
There are several limitations to the Revo. The pacemaker's MRI use is restricted to only certain patients, body parts, and scan settings. The FDA is also requiring a special training program for health professionals who will be using the system.
There are further potential uses for the Revo technology, including for patients who have other types of implanted cardiac devices, such as a heart failure treatment device called cardiac resynchronization therapy (CRT-D). According to a study released earlier this week the CRT-D reduces heart failure in 70 percent of women and researchers are calling for increased use of this device. However, as with pacemakers, MRI use is contradicted with this device and therefore may be a barrier for use.
Although finishing touches are being made on print and warning material to accompany the product, Medtronic will go ahead and begin shipments of the Revo immediately.