MRI-safe pacing lead from Medtronic receives FDA approval
The FDA has approved the CapSureFix Novus MRI SureScan 5076 Lead from Minneapolis-based Medtronic. The lead is approved for MRI scans on any region of the body when paired with a dual-chamber MR-conditional pacemaker.
The 5076 lead had been previously approved for use with non-MR-conditional pacemakers, and the new approval allows two 5076 MRI leads to be paired with dual-chamber Medtronic Advisa MRI or Revo MRI SureScan pacemakers, according to the company.
Approved 5076 MRI lead lengths range from 35cm to 85cm, and patients who previously had two 5076 leads implanted with non-MRI pacemakers will have the option to receive MRIs if MR-conditional SureScan pacemakers are implanted when replacement devices are needed, according to Medtronic.
Evan joined TriMed in 2011, writing primarily for Health Imaging. Prior to diving into medical journalism, Evan worked for the Nine Network of Public Media in St. Louis. He also has worked in public relations and education. Evan studied journalism at the University of Missouri, with an emphasis on broadcast media.