Medtronic Announces New Data Supporting Its PulseSelect Pulsed Field Ablation System

Medtronic announced the results of its clinical study demonstrating a high rate of durable lesion formation for the PulseSelect Pulsed Field Ablation (PFA) System in treating atrial fibrillation (Afib). Results were presented as a late-breaking clinical trial at the Asia Pacific Heart Rhythm Society (APHRS) meeting in Sydney, Australia.
 
Invasive remapping conducted approximately two months post-ablation with the PulseSelect PFA System demonstrated durable isolation in 98% of pulmonary veins (PV) and 96% of patients had all veins isolated.
 
“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,” said Devi Nair, M.D., FHRS, Director of Cardiac Electrophysiology & Research, St. Bernard’s Medical Center & Arrhythmia Research Group, Jonesboro, Arkansas. “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.”
 
The study consisted of 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 were evaluated. Invasive remapping conducted in all patients (57±9 days post-ablation) demonstrated durable isolation in 98% of PVs (102/104), and 96% of patients (24/25) had all veins isolated.
 
The average skin-to-skin procedure time was 36 minutes. Acute PV isolation was achieved in 100% of patients. All index ablation procedures were conducted 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. 
 
Acute PV isolation was achieved in 100% of patients. There were no complications during an average follow-up of 74 days.
 
“These important results clearly address the durability question and add to the real-world evidence for PulseSelect,” said Rebecca Seidel, president, Cardiac Ablations Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. “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.”
 
Over 10,000 cases with PulseSelect have been performed worldwide. In the Asia Pacific (APAC) region, milestones include regulatory approvals in China and Australia and launch in Japan following reimbursement approval.
 
Prof. Hiroshi Tada, Professor of the Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Japan, and President of the Japanese Heart Rhythm Society, said “PulseSelect is the first PFA catheter to receive reimbursement approval in Japanbased 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.”