Medtronic plc announced new clinical data demonstrating the PulseSelect Pulsed Field Ablation (PFA) System's ability to create durable lesions in the treatment of atrial fibrillation (AFib). The study, presented at the Asia Pacific Heart Rhythm Society (APHRS) meeting in Sydney, Australia, showed that invasive remapping conducted approximately two months post-ablation demonstrated durable isolation in 98% of pulmonary veins (PVs). Furthermore, 96% of patients had all veins isolated.
The study evaluated 25 AFib patients with persistent or paroxysmal AFib (56% paroxysmal, 52% male, 69±9 years) undergoing pulmonary vein isolation (PVI) with the PulseSelect PFA System. The primary outcome was durable PV isolation, assessed via invasive remapping 57±9 days post-ablation.
Key Findings on Lesion Durability
Devi Nair, M.D., FHRS, Director of Cardiac Electrophysiology & Research at St. Bernard's Medical Center & Arrhythmia Research Group, emphasized the importance of the findings: "Real-world evidence on chronic lesion formation and durability is critical as use of PFA for the treatment of Afib rapidly increases, making these results impactful and timely for the electrophysiology community. Our research shows that treatment with PulseSelect results in durable lesion formation, which is the cornerstone of successful pulmonary vein isolation and an important addition to previous evidence establishing the safety and effectiveness of this technology."
Procedural Efficiency and Safety
All ablation procedures were performed using intracardiac echocardiography and electroanatomical mapping (EAM) without fluoroscopy. General anesthesia was used in 24 of 25 patients, and all patients were discharged on the same day. The average skin-to-skin procedure time was 36 minutes. Acute PV isolation was achieved in 100% of patients, and no complications were reported during an average follow-up of 74 days.
Global Expansion of PulseSelect
PulseSelect's adoption is growing worldwide, with over 10,000 cases performed. In the Asia Pacific (APAC) region, the system has received regulatory approvals in China and Australia and has been launched in Japan following reimbursement approval.
Prof. Hiroshi Tada, Professor at the Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Japan, and President of the Japanese Heart Rhythm Society, commented on the significance of the approval in Japan: "PulseSelect is the first PFA catheter to receive reimbursement approval in Japan based on clinical trial results that include Japanese patients. We believe that the future widespread availability of this breakthrough technology under insurance coverage will be of great significance in the history of arrhythmia treatment in Japan."
Impact on Atrial Fibrillation Treatment
Atrial fibrillation affects more than 60 million people worldwide and is often undertreated. AFib is a progressive disease, starting as paroxysmal AFib and potentially progressing to persistent AFib, increasing the risk of heart failure, stroke, and death.
Rebecca Seidel, president of the Cardiac Ablations Solutions business at Medtronic, highlighted the broader implications of the study: "These important results clearly address the durability question and add to the real-world evidence for PulseSelect. With expansion in new markets across the Asia Pacific region, physicians around the world are experiencing the benefits of PulseSelect, including proven safety, efficacy, efficiency and now durability as well. We are thrilled to provide this important tool to physicians for the treatment of patients with AFib."
