Abbott launches first human trials of its pulsed field ablation system for afib as the sector grows

With Medtronic and Johnson & Johnson securing international approvals in the nascent domain of pulsed field ablation, Abbott is looking to join the party with its own approach for treating atrial fibrillation and other arrhythmias.

Abbott announced it has begun conducting the first human procedures using its new Volt system, which comes combined with its EnSite X cardiac mapping platform, through a clinical study of more than 30 patients in Australia. 

The company said it plans to examine the device in additional markets across the Asia-Pacific region and in Europe as it takes steps toward securing a CE mark approval. Abbott added that it expects to receive a green light for a U.S. clinical trial in the first half of this year.

Pulsed field ablation employs short bursts of electric energy that disrupt heart muscle cells more than others. The technology aims to avoid generating the excess heat or cold that can cause some of the major complications seen with thermal ablation, such as damage to the surrounding nerves and blood vessels or adjacent vital organs like the esophagus.

Abbott's Volt system uses a balloon-in-basket catheter design to help transfer energy into the cardiac tissue, while EnSite X assists surgeons in accurately positioning the catheter within the heart, with the goal of reducing the need for X-ray radiation exposure and real-time image guidance.

“Daily life for the millions of people with afib can be difficult as symptoms often include palpitations, shortness of breath, dizziness and chest pain, making it critical that physicians treat the issue as soon as possible,” Christopher Piorkowski, chief medical officer of Abbott's electrophysiology business, said in a statement

“With afib cases expected to rise continuously, Abbott's Volt PFA system meets a growing demand for a more innovative solution that reduces the patient procedure time and overall hospital stay, getting them back to living a fuller, longer life,” Piorkowski added.

Last month, Medtronic garnered the FDA’s first approval of a pulsed field ablation system with its PulseSelect hardware. Prior to that, the company received CE marks for PulseSelect and its dual-use Affera catheter that delivers both pulsed field and radiofrequency ablation.

Meanwhile, J&J’s Biosense Webster division recently scored a green light in Japan for its Varipulse platform, bundled with its Carto 3D cardiac mapper. The system is currently under review in Europe.

At the same time, Boston Scientific said it expects to obtain approval from the FDA for its Farapulse catheter by the end of March. That device received a CE mark approval in early 2021, not long before Boston Scientific acquired it and its eponymous developer for $295 million following a lengthy collaboration.

But pulsed field ablation hasn’t just been exclusive to the largest medtechs: Startups, too, have been developing new approaches for what is projected to grow into a multi-billion-dollar market in the coming years.

Cortex, supported by incubator Ajax Health, announced $90 million in financing commitments late last year as it works on an integrated system that can diagnose arrhythmias as well as treat them. Field Medical, meanwhile, collected $14 million in seed funding last September after being launched in 2022 by one of the previous founders of Farapulse.