FDA Clears First MRI-Safe Pacemaker
WASHINGTON -- A cardiac pacemaker that's safe for patients who need an MRI scan has won FDA approval, although the device comes with limitations on which patients and which scans are compatible with it.
The Revo MRI SureScan pacemaker, made by Medtronic, is the first such device to receive marketing clearance in the U.S.
According to the company, the product comes with special leads and other design features that reduce or eliminate certain hazards associated with the MRI environment.
The scanners produce powerful magnetic forces that react with ferric metals and induce electrical currents in electronic components. MRI machines also emit radiofrequency energy that may interact with pacemakers.
As a result, MRI scans can disrupt pacemaker settings or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.
Until now, most MRI scans have been contraindicated for patients with pacemakers. About half of such patients have conditions that would ordinarily call for MRI scans, according to the FDA.
Among the features included in the Revo MRI product is a function to be switched on prior to undergoing an MRI to eliminate problems associated with induced currents and radiofrequency emissions.
The FDA's approval rates the device as "MRI-conditional," meaning that it is safe with MRI scans under certain conditions.
Announcements from the FDA and the company didn't indicate specifically what those conditions would be. Medtronic officials did not respond immediately to a request for details.
However, the major clinical trial underpinning the approval -- presented at a meeting in 2009 and published last month -- only tested the device with MRI machines of no more than 1.5 Tesla and the scanning isocenters were located above the cervical spine or below the thoracic spine.
In the trial, 464 patients received the Revo device and were randomized 1:1 to receive an MRI or not. No scan-related complications were seen in patients who had the scans.
The Revo MRI SureScan pacemaker must be used with special leads designed for the system.
The approval was delayed while the company sought to improve conditions at its Mounds View, Minn., manufacturing plant where its pacemakers are produced. The FDA issued a warning letter about the plant in November 2009 and has not yet declared the problems fully resolved.
Medtronic said it is continuing to work with the agency to satisfy its concerns.
http://www.medicalbillingassistanceinc.com/
The Revo MRI SureScan pacemaker, made by Medtronic, is the first such device to receive marketing clearance in the U.S.
According to the company, the product comes with special leads and other design features that reduce or eliminate certain hazards associated with the MRI environment.
The scanners produce powerful magnetic forces that react with ferric metals and induce electrical currents in electronic components. MRI machines also emit radiofrequency energy that may interact with pacemakers.
As a result, MRI scans can disrupt pacemaker settings or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.
Until now, most MRI scans have been contraindicated for patients with pacemakers. About half of such patients have conditions that would ordinarily call for MRI scans, according to the FDA.
Among the features included in the Revo MRI product is a function to be switched on prior to undergoing an MRI to eliminate problems associated with induced currents and radiofrequency emissions.
The FDA's approval rates the device as "MRI-conditional," meaning that it is safe with MRI scans under certain conditions.
Announcements from the FDA and the company didn't indicate specifically what those conditions would be. Medtronic officials did not respond immediately to a request for details.
However, the major clinical trial underpinning the approval -- presented at a meeting in 2009 and published last month -- only tested the device with MRI machines of no more than 1.5 Tesla and the scanning isocenters were located above the cervical spine or below the thoracic spine.
In the trial, 464 patients received the Revo device and were randomized 1:1 to receive an MRI or not. No scan-related complications were seen in patients who had the scans.
The Revo MRI SureScan pacemaker must be used with special leads designed for the system.
The approval was delayed while the company sought to improve conditions at its Mounds View, Minn., manufacturing plant where its pacemakers are produced. The FDA issued a warning letter about the plant in November 2009 and has not yet declared the problems fully resolved.
Medtronic said it is continuing to work with the agency to satisfy its concerns.
http://www.medicalbillingassistanceinc.com/
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