FDA Expands Approval of Medtronic’s Cardiac Pacing Lead
The FDA has expanded its approval of Medtronic’s SelectSecure MRI SureScan Model 3830 cardiac lead for pacing and sensing.
The thin lead, which uses an approach known as "conduction system pacing," taps into the heart's natural electrical system. The approach helps ensure that pacing closely mimics the heart's physiologic contractions, allowing the heart's ventricles to work in coordination, the company said.
The device was first approved in 2018 for conduction system pacing via the His bundle — a group of fibers that carry electrical impulses through the heart. It is now approved for use in the left bundle branch area as an alternative to right ventricular pacing.