Medtronic’s PulseSelect Study Paves the Way for PFAMedtronic’s PulseSelect Study Paves the Way for PFA

The Dublin-based company won FDA approval for its pulsed field ablation technology late last year.

Omar Ford

September 30, 2024

2 Min Read
PulseSelect PFA system
PulseSelect PFA systemImage Courtesy of Medtronic

Pulsed Field Ablation (PFA) procedures gained a big victory after Medtronic revealed favorable data for the PulseSelect system.

The Results presented at the Asia Pacific Heart Rhythm Society (APHRS) meeting in Sydney, Australia, show that the Dublin-based company’s PulseSelect demonstrated excellent lesion durability.

A total 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.

"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."

The company said the broad adoption of PulseSelect continues worldwide, with more than 10,000 cases being performed worldwide. In the Asia Pacific (APAC) region, milestones include regulatory approvals in China and Australia and launch in Japan following reimbursement approval.

Related:Medtronic Steals the Spotlight in PFA

PFA procedures to treat atrial fibrillation have been on the upswing since late last year. In December, Medtronic was the first company in the space to win approval in the PFA market in the US – making it to the finish line before Boston Scientific and Johnson & Johnson.

Boston Scientific followed shortly, winning approval for the Farapulse PFA in January. The device was one of the most highly-anticipated medical device approvals of 2024. Marlborough, MA-based Boston Scientific began investing in Farapulse in 2014. The company signaled its intent to buy Farapulse in 2020 and acquired the company in 2021 after the device was CE-marked.

Johnson & Johnson is still seeking approval. However, earlier this year, the company unveiled promising results from the inspIRE for the Varipulse System at the 29th Annual International AF Symposium.

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

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