Medtronic has received US Food and Drug Administration (FDA) approval for expanded labelling for the SelectSecure Model 3830 cardiac lead for left bundle branch area pacing.
In 2018, the FDA approved the lead for His-Bundle pacing, another form of conduction system pacing.
“Conduction system pacing is more like simulating natural activation and can yield positive outcomes for patients,” said Pugazhendhi Vijayaraman (Geisinger Heart Institute, Wilkes-Barre, USA). “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.”
The SelectSecure Model 3830 lead received approval for left bundle branch area pacing based on real-world evidence showing high procedural success rates at 92%, and low procedural complication rates at 2.5%.
“Physicians are telling us about their excitement for the future of pacemakers, which will rely on conduction system and leadless pacing,” said Robert Kowal, general manager, Cardiac Pacing Therapies, within the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. “Expanded labelling of this lead allows us to train physicians to successfully perform left bundle procedures, bringing the benefits of conduction system pacing to more patients.”