Medtronic has obtained an approval from the US Food and Drug Administration (FDA) for its Advisa DR MRI and Revo MRI SureScan pacing systems for use with magnetic resonance imaging (MRIs) scans without positioning restrictions.
Previously, the company has obtained the FDA approval for the SureScan pacing systems for MRI scans with positioning restrictions. These devices were restricted for MRI scans in chest area.
Revo MRI has been approved by the FDA in February 2011 and Advisa MRI in January 2013.
The FDA has now approved the devices for use with MRI scans positioned on any region of the patient body. This approval is based on the agency’s review of computer modeling and clinical data confirming that MRI chest-positioned scans are safe for patients.
Medtronic Cardiac Rhythm Disease Management business president Pat Mackin and senior vice president noted this approval allows for a more streamlined MRI scanning process and makes scanning the chest easier and more accessible for patients with pacemakers.
"Because MRI is the standard of care for soft tissue imaging and is a critical component for early detection, diagnosis and treatment, this FDA approval will help more patients with SureScan pacemakers receive the MRI scans they need," Mackin added.
Until the availability of Medtronic’s SureScan pacemakers, US patients had been contraindicated from receiving MRI scans due to potential interactions between the MRI and device function.
Medtronic claims that its SureScan pacemakers are the first and only pacing systems in the US that have been approved by the FDA for use with MRI.