Medtronic (NYSE:MDT) said today that the FDA approved its CapSureFix Novus MRI SureScan 5076 lead in MRI scans for patients with a Medtronic dual-chamber MR-conditional pacemaker.
The 5076 lead was already approved for use with Medtronic’s non-MR-conditional pacemakers, according to a press release. The new approval allows the lead to be paired with the Minneapolis-area medical device giant’s Advisa MRI or Revo MRI SureScan pacemakers.
"The 5076 lead has proven to be 1 of the most reliable pacing leads for more than a decade, and due to extensive testing, now also can undergo MRI scans," bradycardia general manager Brian Urke said in prepared remarks. "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."
Last April Medtronic launched launched a 275-patient U.S. clinical trial of its Evera SureScan ICD after winning CE Mark approval in the European Union for the device.
The Revo device won an FDA nod in February 2011. Medtronic’s CapSure Sense SureScan leads won CE Mark approval in March 2012.
