Medtronic has announced new clinical study results showcasing a high durable lesion formation rate for the PulseSelect pulsed field ablation (PFA) system in atrial fibrillation (Afib) treatment.
The study, presented at the Asia Pacific Heart Rhythm Society meeting, indicated that 98% of pulmonary veins remained isolated approximately two months post-ablation.
The study involved 25 patients with persistent or paroxysmal Afib, demonstrating a 98% durability rate in pulmonary vein isolation (PVI) using the PulseSelect PFA system.
Invasive remapping conducted on average 57 days post-ablation showed that 96% of patients had all veins isolated.
All index ablation procedures were performed using intracardiac echocardiography and electroanatomical mapping, avoiding fluoroscopy.
The majority of patients were under general anaesthesia, and the average skin-to-skin procedure time was recorded at 36 minutes.
With acute PV isolation achieved in 100% of patients and no complications reported during an average follow-up of 74 days, the data underscores the system's safety and effectiveness.
Medtronic cardiovascular portfolio’s cardiac ablations solutions business president Rebecca Seidel said: “These important results clearly address the durability question and add to the real-world evidence for PulseSelect.
“With an 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.”
The PulseSelect PFA system has seen broad adoption, with more than 10,000 cases performed globally, including regulatory approvals and launches in the Asia Pacific region.
Afib affects over 60 million individuals worldwide and remains one of the most common yet undertreated heart rhythm disorders.
Before this development, Medtronic announced a partnership with Siemens Healthineers to expand access to advanced imaging technologies within the field of spine care.
