Medtronic First To Secure FDA Nod For Pacing Heart's Natural Conduction System

The FDA has approved Medtronic plc's MDT 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.
Commonly referred to as "conduction system pacing," this approach helps ensure that pacing mimics the heart's physiologic contractions, allowing the heart's ventricles to work in coordination.
Also see: Medtronic Recalls HeartWare HVAD System Batteries For Electrical Faults.
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).
Last month, the FDA granted 510(k) clearance to Medtronic's LINQ II Insertable Cardiac Monitor (ICM) system for use in pediatric patients over two who have heart rhythm abnormalities and require long-term care and continuous monitoring.
Price Action: MDT shares are up 1.84% at $83.11 on the last check Monday.

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