Medtronic’s SelectSecure MRI SureScan Model 3830 Cardiac Lead Approved for Expanded Indication for Conduction System Pacing

October 17, 2022—Medtronic announced it has received FDA approval for expanded labeling of the company’s SelectSecure MRI SureScan Model 3830 cardiac lead for conduction system pacing, which helps ensure that pacing closely mimics the heart’s physiologic contractions, allowing the heart’s ventricles to work in coordination.

Medtronic advised that the MR-conditional, steroid-eluting, bipolar SelectSecure Model 3830 lead was originally indicated in the United States for pacing and sensing in the atrium or right ventricle. In 2018, the FDA approved Model 3830 for His Bundle 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 bradycardia.

According to the company, real-world evidence has demonstrated high procedural success rates at 92% and low procedural complication rates at 2.5%.

“Conduction system pacing is more like simulating natural activation and can yield positive outcomes for patients,” commented Pugazhendhi Vijayaraman, MD, in the company’s press release. “This approval signals to physicians that the Model 3830 lead is safe and effective for patients for conduction system pacing, and it may encourage more physicians to learn the procedure.” Dr. Viijayaraman is Director of Electrophysiology at Geisinger Heart Institute in Wilkes-Barre, Pennsylvania.