Abbott is joining the worldwide race to make pulsed field ablation the standard procedure for atrial fibrillation with an approval in Europe for its Volt system.
Boston Scientific, Medtronic and Johnson & Johnson have had a yearslong head start on the continent with their respective platforms, but Abbott described its goal as aiming to overcome some of the limitations of current systems—such as by ensuring clinicians know when the Volt catheter is in contact with cardiac tissue.
The company said that with the earlier-than-expected CE mark in hand, it has already begun logging commercial pulsed field ablation cases in Austria, Germany, Belgium and the Netherlands among physicians who had participated in Volt’s clinical studies. Abbott said it plans to broaden its rollout across the EU in the latter half of this year.
“While PFA is a relatively new therapy option, we've incorporated lessons learned from first-generation devices and designed the Volt system to simplify PFA procedures while making them more efficient,” the chief medical officer of Abbott’s electrophysiology business, Christopher Piorkowski, said in a statement, citing clinical data that demonstrated pulmonary vein isolations with fewer ablation attempts.
The Volt system employs a balloon-in-basket design for a single-shot ablation approach and can work with Abbott’s EnSite X 3D mapping system to help plot procedures and provide live feedback without having to swap out catheters.
The Farapulse pulsed field ablation system received its first CE mark in early 2021, shortly before it was acquired by Boston Scientific. More recently, the company’s updated Farawave Nav catheter with integrated mapping received its European green light last month.
Medtronic, meanwhile, got the continental go-ahead for its Affera system and Sphere-9 catheter in March 2023, with J&J following up with its Varipulse hardware in February 2024.
Abbott estimates that about 8 million people in Europe over the age of 65 have been diagnosed with afib, and the company said it expects that number to double over the next 30 years.