FDA approves Abbott’s new defibrillation lead for conduction system pacing
Abbott has secured U.S. Food and Drug Administration (FDA) approval for its UltiSynq defibrillation lead capable of delivering both cardiac pacing and defibrillation therapy. The device received CE mark approval as well.
These approvals come as conduction system pacing, which uses the heart’s electrical pathways to regulate the heart, continues to gain momentum among electrophysiologists. The UltiSynq defibrillation lead was built for long-term attachment to compatible implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) systems in select patients facing an increased risk of sudden cardiac death due to tachyarrhythmias. It is implanted in a patient’s left bundle branch area, providing clinicians with a new option for left bundle branch area pacing (LBBAP).
The UltiSynq defibrillation lead’s safety and effectiveness were confirmed in the ASCEND CSP IDE trial, a multicenter study of the device in approximately 200 patients. Overall, successful implants were reported for 98.5% of patents and the mean number of reposition attempts was less than one per patient. In addition, left bundle branch pacing or likely left bundle branch pacing was achieved for 86% of patients, and the other 14% of patients had left ventricular septal pacing. After three months, 97.5% of patients were free of complications.
“UltiSynq demonstrates what is achievable when a lead is designed to support conduction system pacing,” Pugazhendhi Vijayaraman, MD, system director of cardiac electrophysiology at Geisinger Heart Institute in Danville, Pennsylvania, said in a statement. “The observed implant success, LBBAP capture results, and defibrillation testing outcomes give physicians compelling data on this lead option for patients who require defibrillation protection and are candidates for conduction system pacing.”
“UltiSynq represents an important advance as Abbott continues to build a comprehensive cardiac rhythm management portfolio,” added Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business, in the same statement. “Physicians now have a compelling option for conduction system pacing in patients who also need ICD or CRT-D therapy. UltiSynq extends physiologic pacing to patients who require both rhythm management and defibrillation protection.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.