US-based Medtronic has obtained expanded approval from the US Food and Drug Administration (FDA) for its SureScan pacing systems, which have been branded safe for magnetic resonance imaging (MRI) scans positioned on any region of the body.
These are reportedly the first and only pacing systems in the US that have been approved by the FDA for use with MRI.
With this new approval, patients implanted with the Advisa DR MRI or Revo MRI SureScan pacing systems can undergo MRI scans without positioning restrictions, including the chest area, which had previously been restricted.
Medtronic senior vice-president Pat Mackin said 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 said.
In general patients with pacemakers do not receive MRI scans because of the potential that the MRI machine could interfere with the device function.
According to the company, around 75% of patients worldwide with implanted cardiac devices are estimated to need an MRI scan during the lifetime of their devices.
The recent approval was made following the FDA review of computer modeling and clinical data confirming that MRI chest-positioned scans are safe for patients.
The FDA approved the first MRI compatible pacemaker available in the US, the Medtronic’s Revo MRI, in February 2011. A second generation Advisa MRI was approved by the FDA in January 2013.
Image: Advisa DR MRI SureScan pacing system. Photo: courtesy of Medtronic Inc.