Key Takeaways
- The PulseSelect Pulsed Field Ablation System achieves durable pulmonary vein isolation in 98% of cases.
- The system has broad regulatory approval across the Asia Pacific region, including China, Australia, and Japan.
- All procedures in the study were completed without fluoroscopy, reducing radiation exposure for patients.
- The PulseSelect PFA System’s rapid adoption highlights its effectiveness and efficiency.
Medtronic, a global healthcare technology leader, has unveiled promising clinical study results for its PulseSelect™ Pulsed Field Ablation (PFA) System at the Asia Pacific Heart Rhythm Society (APHRS) meeting in Sydney, Australia. The system has shown exceptional long-term durability in treating atrial fibrillation (Afib), a common heart rhythm disorder. In a study involving 25 patients, the system achieved durable isolation in 98% of pulmonary veins, with 96% of patients having all veins isolated. These results reinforce the effectiveness and safety of the PulseSelect PFA System, signaling a significant advancement in Afib treatment.
The study, which included patients with persistent or paroxysmal Afib, demonstrated the efficacy of the PulseSelect Pulsed Field Ablation System in achieving durable pulmonary vein isolation. Invasive remapping conducted approximately two months post-ablation revealed that 98% of pulmonary veins remained isolated, and 96% of patients had all veins isolated. The procedures were performed using intracardiac echocardiography and electroanatomical mapping without fluoroscopy, and all patients were discharged on the same day without complications.
Global Success of PulseSelect Pulsed Field Ablation System: Key Approvals and Milestones in Afib Treatment
Dr. Devi Nair, Director of Cardiac Electrophysiology & Research at St. Bernard’s Medical Center, emphasized the importance of these findings, noting that durable lesion formation is crucial for successful pulmonary vein isolation. The study results add to the growing body of evidence supporting the safety and efficacy of the PulseSelect Pulsed Field Ablation System in treating Afib.
The PulseSelect PFA System has gained significant traction globally, with over 10,000 cases performed worldwide. Recent milestones in the Asia Pacific region include regulatory approvals in China and Australia and a successful launch in Japan following reimbursement approval. Professor Hiroshi Tada, President of the Japanese Heart Rhythm Society, highlighted the significance of this technology in Japan, noting that it is the first Pulsed Field Ablation catheter to receive reimbursement approval based on clinical trial results that included Japanese patients.
Medtronic Expands PulseSelect Pulsed Field Ablation System, Advancing Afib Treatment Globally
Rebecca Seidel, President of the Cardiac Ablations Solutions business at Medtronic, expressed enthusiasm about the system’s expansion into new markets. She noted that the PulseSelect Pulsed Field Ablation System offers proven safety, efficacy, efficiency, and now, confirmed durability, providing a valuable tool for physicians treating Afib patients.
Atrial fibrillation affects over 60 million people worldwide, often leading to serious complications such as heart failure and stroke. The PulseSelect PFA System represents a significant advancement in Afib treatment, providing a durable and efficient solution for pulmonary vein isolation. As the system gains regulatory approval and adoption in new markets, it offers a promising option for patients and physicians alike. Medtronic’s commitment to innovative healthcare technology continues to drive improvements in patient outcomes, addressing the global burden of cardiovascular diseases.
Resource: Medtronic, September 27, 2024
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