- The Food and Drug Administration has approved an expanded label for Medtronic’s SelectSecure Model 3830 cardiac lead.
- Medtronic received FDA clearance to use its cardiac pacing lead in the bundle of His, a group of muscle fibers that carry electrical impulses through the center of the heart, in 2018. The latest FDA decision expands the SelectSecure label to cover left bundle branch area pacing.
- The left bundle branch area has emerged as an alternative to pacing of both the right ventricle and the His bundle on the strength of clinical evidence that it has a high success rate and few complications.
Medtronic has moved to corner the market for conduction system pacing, a term that covers His-bundle pacing and left-bundle branch pacing. Advocates of the approach argue it closely mimics the heart's physiologic contractions and thereby coordinates the activity of the ventricles, resulting in better outcomes for patients with heart failure and conduction abnormalities.
After securing authorization in His-bundle pacing, Medtronic sought to validate its lead in the pacing of the left bundle branch. The company has generated real-world evidence showing the approach has a 92% procedural success rate and a 2.5% complication rate.
As the real-world evidence suggests, physicians have been using the 3830 lead in left-bundle branch pacing and have published multiple papers about their experiences. Medtronic expects the receipt of FDA approval to help it expand use of the approach.
“Expanded labeling of this lead allows us to train physicians to successfully perform left bundle procedures, bringing the benefits of conduction system pacing to more patients,” Dr. Robert Kowal, general manager of cardiac pacing therapies at Medtronic, said in a statement.
The 3830 lead was originally indicated in the U.S. for pacing and sensing in the atrium or right ventricle but Medtronic has expanded the label over time.