Medtronic has announced new, positive clinical study results for the PulseSelect Pulsed Field Ablation (PFA) System in treating atrial fibrillation (Afib).
The study showed a high rate of durable lesion formation in real-world settings.
The PulseSelect PFA system offers rapid, effective pulmonary vein isolation (PVI). It ensures consistent and predictable energy delivery along with improved catheter manoeuvrability.
Moreover, the system is designed to integrate smoothly into a clinician’s preferred workflow.
PulseSelect PFA System received approval from the US Food and Drug Administration (FDA) in December 2023.
The late-breaking clinical trial included invasive remapping nearly two months after the ablation.
The PulseSelect PFA System demonstrated durable isolation in 98% of pulmonary veins (PV). Additionally, 96% of patients had all veins isolated.
These findings were presented at the Asia Pacific Heart Rhythm Society (APHRS) meeting in Sydney, Australia.
The study evaluated 25 patients with persistent or paroxysmal AFib and undergoing PVI with the PulseSelect PFA System.
All index ablation procedures utilised intracardiac echocardiography and electroanatomical mapping (EAM) without fluoroscopy. General anaesthesia was administered to 24 patients, and all were discharged on the same day.
The average skin-to-skin procedure time was 36 minutes. Acute PV isolation was achieved in all patients, with no complications reported during an average follow-up of 74 days.
Medtronic cardiovascular portfolio 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 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.”
The PulseSelect system is said to have been used in over 10,000 cases globally.
In the Asia Pacific (APAC) region, significant milestones include regulatory approvals in China and Australia, as well as its launch in Japan after receiving reimbursement approval.
Recently, Medtronic reported positive long-term results from the global Extravascular Implantable Cardioverter Defibrillator (EV ICD) trial of its Aurora EV-ICD system.
