Medtronic First to Receive FDA Approval for Pacing the Heart's Natural Conduction System

 Medtronic plc (NYSE: MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval for expanded labeling of a cardiac lead that taps into the heart's natural electrical system, giving patients needed therapy while avoiding complications sometimes associated with traditional pacing methods, such as cardiomyopathy.1 Commonly referred to as "conduction system pacing," this approach helps ensure that pacing closely mimics the heart's physiologic contractions, allowing the heart's ventricles to work in coordination.1

Medtronic is the first and only company with therapies approved for conduction system pacing. In 2018, the FDA approved the SelectSecure™ MRI SureScan® Model 3830 cardiac lead for His-Bundle pacing, another form of conduction system pacing. Now this cardiac lead is approved for pacing and sensing at the bundle of His or in the left bundle branch area as an alternative to apical pacing in the right ventricle in a single- or dual-chamber pacing system. These implanted pulse generator systems help patients who experience slow heart rates (bradycardia).

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