Pacing Lead for Full-Body MRI Scans Approved for Use in Patients with a Slow Heartbeat

(Minneapolis, MN, USA) announced the US Food and Drug Administration (FDA) approval of its CapSureFix Novus MRI SureScan 5076 lead, previously approved for use with Medtronic’s non-MR-conditional pacemakers, has been well-received because of its handling and effectiveness. Since its introduction more than 10 years ago, physicians have implanted more than three million 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 35–85 cm. 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,” 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.”

Since its first MR-conditional pacing system was approved in Europe in 2008, Medtronic has continued to design and test its products for safe use during MRI scanning. Recent developments in computer modeling have allowed Medtronic to evaluate the 5076 lead across more than two million scanning situations. Furthermore, Medtronic conducted the 5076 MRI Clinical Study, global, multicenter research to evaluate the safety and effectiveness of the 5076 lead in the MRI environment.

Worldwide, it is estimated that up to 75% of patients with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices. MRI is the standard of care in soft tissue imaging, providing data not seen with X-ray, ultrasound, or computed tomography (CT) scan. MRI is therefore crucial for the early detection and treatment of many diseases. Until recently, patients with implanted pacemakers were refused access to MRI procedures because the interaction can be injurious.

The 5076 MRI lead is the latest addition to a range 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. Moreover, the Evera MRI SureScan implantable cardioverter-defibrillator (ICD) system is investigational in the United States.

In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers a wide range of novel medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

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