Abbott’s Volt pulsed field ablation system scores FDA approval

 After claiming its approval in Europe earlier this year, Abbott has secured the FDA’s go-ahead for its Volt pulsed field ablation system for irregular heart rhythms, a step forward in an international race as clinicians continue to adopt the new technology.

With the U.S. green light, Abbott’s newcomer will compete with hardware that has had a head-start from Boston Scientific, Medtronic, Johnson & Johnson and more. Abbott hopes its approach—including an all-in-one minimally invasive catheter capable of 3D heart mapping, pacing and ablation—will help carry it into more cath labs by offering improvements over first-generation platforms. 

For example, Abbott said that patients undergoing a Volt procedure can be placed under conscious sedation instead of general anesthesia, while also reducing the radiation exposure that comes with X-ray fluoroscopy. 

“We heard the physician feedback that patients need an alternative to general anesthesia during a PFA ablation procedure that doesn't sacrifice strong outcomes,” Christopher Piorkowski, chief medical officer of Abbott's electrophysiology business, said in a statement. “The Volt PFA System is an option for patients who prefer conscious sedation, which can also lead to faster recovery times and shorter procedures for the millions of Americans who suffer from an abnormal heart rhythm.”

Abbott estimates that 12 million people in the U.S. over age 65 live with the arrhythmia known as atrial fibrillation, or afib, which carries a significantly increased risk of stroke. The company said that figure is also expected to double within the next two decades.

Pulsed field systems aim to improve upon previous thermal ablation hardware by limiting the potential for damaging nearby healthy tissues, including important nerves and organs such as the esophagus. They operate by generating an electric field that selectively disrupts the cardiac muscle tissue carrying arrhythmia signals.

The Volt works with Abbott’s EnSite X EP mapping platform and features a balloon-filled basket design with eight active ribs. In previous clinical studies, the device showed that after six months, 93.1% of intermittent afib patients were recurrence-free, as well as 81.9% of those with persistent afib.

Additionally, among procedures performed with a zero-fluoroscopy workflow, the company said 15 of 16 cases achieved pulmonary vein isolation on the first pass, with zero immediate complications. About 70% of the cases were completed without general anesthesia. 

The FDA’s approval covers Volt’s use in symptomatic afib, including persistent and intermittent cases, that haven’t responded to standard drug therapies. The system claimed a CE Mark in March, which the company described at the time as "earlier than expected." 

Earlier this month, Boston Scientific secured a European approval for its focal PFA catheter, the Farapoint. It joins the Farapulse platform, adding the ability to treat right atrial flutter and deliver ablations to the cavotricuspid isthmus area of the heart.

Meanwhile, the FDA approved Kardium’s Globe catheter in September, designed to provide single-shot isolations of the pulmonary veins, which serve as the origin points for most cases of afib.

https://www.fiercebiotech.com/medtech/abbotts-volt-pulsed-field-ablation-system-scores-fda-approval