This process is commonly referred to as “conduction system pacing,” according to Medtronic. It gives patients needed therapy while avoiding complications sometimes associated with traditional pacing methods, like cardiomyopathy.
Fridley, Minnesota-based Medtronic said this helps to ensure that pacing closely mimics the heart’s physiologic contractions. It allows the heart’s ventricles to work in coordination. The SelectSure MRI SureScan Model 3830 first received FDA approval in 2018 for HIS-Bundle pacing.
The cardiac lead’s expanded approval covers pacing and sensing at the HIS-Bundle or in the left bundle branch area. It represents an alternative to apical pacing in the right ventricle in a single- or dual-chamber pacing system. The implanted pulse generator system helps those with slow heart rates (bradycardia), Medtronic said.
A first for Medtronic
Medtronic says the approval makes it the first company to receive a nod for pacing the heart’s natural conduction system.
“Conduction system pacing is more like simulating natural activation and can yield positive outcomes for patients,” said Pugazhendhi Vijayaraman, M.D., F.H.R.S., director of electrophysiology at Geisinger Heart Institute in Wilkes-Barre, Pennsylvania. “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.”
Real-world evidence showed high procedural success rates at 92%. It also demonstrated low complication rates at 2.5% in the left bundle branch area.
“Physicians are telling us about their excitement for the future of pacemakers, which will rely on conduction system and leadless pacing,” said Dr. Robert C. Kowal, GM, cardiac pacing therapies at Medtronic. “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.”