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The US Food and Drug Administration (FDA) has approved an expanded indication for the SelectSecure™ MRI SureScan Model 3830 cardiac lead to include left bundle brand area pacing, according to a statement from Medtronic.
Announced on October 17, the company’s statement suggests the expanded indication, which is based on evidence from multiple sources across a population exceeding 20,000 patients, means the SelectSecure™ MRI SureScan Model 3830 cardiac lead is the first and only lead approved for conduction system pacing.
"Conduction system pacing is more like simulating natural activation and can yield positive outcomes for patients," said Pugazhendhi Vijayaraman, MD, FHRS director of electrophysiology at Geisinger Heart Institute, in the aforementioned statement. “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."
According to their release, Medtronic is the first and only company with therapies approved for conduction system pacing. The SelectSecure MRI SureScan Model 3830 cardiac lead, which received initial approval in 2018 for His-Bundle pacing, is now 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. In the evidence used to support the expanded indication, real-world data suggested use of the lead was associated with a procedural success rate of 92% and a procedural complications rate of 2.5%, according to a systematic review and meta-analysis due to be presented at 15th Asia Pacific Heart Rhythm Society Scientific Session in November.
In their release, Medtronic highlighted numerous other “firsts” for the company in cardiac pacing innovation, including the first leadless pacemaker in the Micra Transcatheter Pacing System, the fist pacemaker approved for use in MRIs, and the first wearable pacemaker, which was invented by Medtronic founder Earl Bakken in 1957.
“Physicians are telling us about their excitement for the future of pacemakers, which will rely on conduction system and leadless pacing,” said Robert C. Kowal, MD, PhD general manager of Cardiac Pacing Therapies within the Cardiac Rhythm Management business 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."