SelectSite C304-HIS Catheter Earns FDA Nod for His Bundle Pacing

Patrice Wendling

May 29, 2019

The US Food and Drug Administration (FDA) has cleared the SelectSite C304-HIS deflectable catheter system for use in His-bundle pacing procedures, Medtronic announced today.

The SelectSite C304-HIS catheter system features an adjustable, out-of-plane curve that should help implanters reach the His-bundle fibers more easily and accommodate a variety of patient anatomies, including large right atria, according to the news release.

The new catheter system also facilitates placement of Medtronic's SelectSecure MRI SureScan model 3830 cardiac pacing lead, which is intended for pacing and sensing in the atrium or right ventricle and is the only pacing lead approved in the United States for His-bundle pacing.

His-bundle pacing is an alternative to right-ventricular pacing, in which a pacing lead is placed at or near the bundle of His, leveraging the heart's native His–Purkinje conduction system to restore normal rhythm.

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