The US Food and Drug Administration (FDA) has given approval for Medtronic’s CapSureFix Novus MRI SureScan 5076 lead, which will be used with magnetic resonance imaging (MRI).
The lead can be positioned on any region of the body when paired with the firm’s dual-chamber MR-conditional pacemaker.
Earlier this year, the 5076 lead was approved for use with the company’s non-MR-conditional pacemakers, which was well-received because of its handling and proven reliability, the company said.
The new approval allows two 5076 MRI leads to be paired with dual-chamber Medtronic Advisa MRI or Revo MRI SureScan pacemakers, which helps patients to undergo full-body MRI scans.
The company noted that 5076 MRI lead lengths approved for these scans range in length from 35cm to 85cm.
Medtronic bradycardia business vice-president Brian Urke said: "The 5076 lead has proven to be one of the most reliable pacing leads for more than a decade, and due to extensive testing, now also can undergo MRI scans.
"This is especially important for patients who need MRIs and received 5076 leads at the time of their initial implants; although they may not have received MR-conditional pacemakers initially, they now have the option to get a pacemaker approved for MRI when they require a device change-out, making the entire system MR-conditional."
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, the company said.
The company also produces SureScan neurostimulation systems for the management of chronic pain, and the SynchroMed II programmable drug infusion system.