Medtronic has announced the US Food and Drug Administration (FDA) approval of its CapSureFix Novus MRI SureScan 5076 lead for use with magnetic resonance imaging (MRI).
According to a company release, the lead is approved for MRI scans positioned on any region of the body when paired with a Medtronic dual-chamber MR-conditional pacemaker.
The 5076 lead has been in the market for more than 10 years, a press release states that physicians have implanted more than three million 5076 leads in patients. In order to evaluate the safety and effectiveness of the 5076 lead in the MRI environment, Medtronic conducted the 5076 MRI clinical study, a global, multicentre study.
With the new FDA approval, two 5076 MRI leads can now be paired with dual-chamber Medtronic Advisa MRIor Revo MRI SureScan pacemakers, allowing patients with these complete SureScan pacing systems to undergo full-body MRI scans. Medtronic 5076 MRI lead lengths approved for these scans range in length from 35cm to 85cm. 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 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,” says Brian Urke, vice president and general manager of the bradycardia business at Medtronic. “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.”
The 5076 MRI lead is the latest addition to a growing number of Medtronic devices that are approved for MRI access. These include the Medtronic SureScan pacing systems, the SureScan neurostimulation systems for the management of chronic pain, and the SynchroMed II programmable drug infusion system, which are available worldwide. Additionally, the Evera MRI SureScan implantable cardioverter-defibrillator (ICD) system is investigational in the USA.