Pacing Lead Approval for MR-Conditional Use in Bradycardia Patients

The U.S. FDA has approved Medtronic’s CapSureFix Novus™ MRI SureScan® 5076 Lead for use with magnetic resonance imaging (MRI). The lead is approved for MRI scans positioned on any region of the body when paired with a Medtronic dual-chamber MR-conditional pacemaker.

Background

MRI conditionality is rapidly becoming a buzz phrase in the world of cardiac devices. This is because estimates suggest that up to 75 percent of patients with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices. Until recently, patients with implanted pacemakers were denied access to MRI procedures because the interaction can be harmful.

Medtronic says that since its introduction more than 10 years ago, physicians have implanted more than 3 million of the so-called 5076 leads in patients. With the new FDA approval, two 5076 MRI leads can now be paired with dual-chamber Medtronic Advisa MRI™ or 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.

Company comments

“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,” said 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.”

Source: Medtronic, Inc.

Share your thoughts

Your email address will not be published. Required fields are marked *