US-based Medtronic has received approval from the US Food and Drug Administration (FDA) for its 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 firm’s dual-chamber MR-conditional pacemaker.
Earlier, the 5076 lead received approval to use with company’s non-MR-conditional pacemakers.
Medtronic bradycardia business vice president and general manager Brian Urke said the 5076 lead is one of the most reliable pacing leads 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," Urke added.
The new approval allows two 5076 MRI leads to pair with dual-chamber Medtronic Advisa MRI or Revo MRI SureScan pacemakers, which helps patients to undergo full-body MRI scans.
Medtronic noted that 5076 MRI lead lengths approved for these scans range in length from 35cm to 85cm.
The company also produces SureScan neurostimulation systems for the management of chronic pain, and the SynchroMed II programmable drug infusion system.
Image: The world headquarters of Medtronic, Fridley, Minnesota, USA. Photo: courtesy of Bobak Ha’Eri.