Medtronic receives recommendation over new pacemaker

Medtronic has received the backing of a Food and Drug Administration (FDA) panel for a new pacemaker system which is safe for use with Magnetic Resonance Imaging (MRI) systems.

The regulator’s circulatory system devices panel of the medical devices advisory committee unanimously voted in favour of the Revo MRI SureScan pacing system receiving FDA approval.

This recommendation came on the back of positive clinical trial results showing the system’s safety and efficacy, as well as its MR conditional nature.

If Revo MRI is ratified, it will be the first FDA-approved pacemaker designed to be used in the MRI setting, allowing many patients who are currently recommended not to have the scans to receive treatment.

Pat Mackin, president of the cardiac rhythm disease management business and senior vice-president at Medtronic, said: “We look forward to working with the FDA during the regulatory process so that we may provide certain pacemaker patients with access to MRI scans.”

This comes after the FDA’s neurological devices panel last week voted in favour of Medtronic’s Deep Brain Stimulation therapy to be approved as a treatment for epilepsy patients.