Medtronic Wins Expanded Use of 5076 Pacer Leads
The FDA has approved the use of Medtronic’s CapSureFix Novus MRI SureScan 5076 leads for with full-body MRI scans when paired with a Medtronic dual-chamber magnetic resonance-conditional pacemaker, the company said Monday. The leads were previously approved only for use with the company’s non-MR-conditional pacemakers.
Medtronic makes two MR-compatible pacemakers: the dual-chamber Advisa and the Revo SureScan. The 5076 is available lengths ranging from 35cm to 85cm, the Minneapolis, Minn., devicemaker said.
According to Brian Urke, a Medtronic vice president and general manager of bradycardia, patients who currently have 5076 leads with non-MR-conditional pacemakers may request an MRI-approved pacemaker during a device change-out, making the entire system MR-conditional.
The supplemental approval was based on a global, multicenter study and over 2 million computer-based scanning scenarios. The 5076 lead was CE-marked for MRI in 2013. — Kellen Owings
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