Volt treats patients battling common abnormal heart rhythms like AFib. It marks Abbott’s entry into the crowded pulsed field ablation (PFA) space alongside companies like Medtronic, Boston Scientific and Johnson & Johnson’s Biosense Webster.
Last month, Medtronic became the first company to win an FDA nod for PFA to treat paroxysmal and persistent AFib. Boston Scientific anticipates FDA approval for its Farapulse PFA system in the first quarter of this year.
Doctors treated more than 30 patients in Australia as part of the Abbott Volt CE mark study. The pre-market, multi-center trial aims to evaluate Volt’s safety and effectiveness. Abbott anticipates upcoming procedures in Asia Pacific and Europe. The company also expects FDA approval for an investigational device exemption (IDE) trial in the first half of this year.
Dr. Prash Sanders, director of the Centre for Heart Rhythm Disorders at the University of Adelaide, Australia, conducted the first Volt procedures.
“Abbott has designed a novel PFA solution that, when combined with its EnSite X cardiac mapping system, can address hard-to-treat irregular heartbeats with a level of accuracy and precision that‘s never before been possible,” Sanders said in a news release.
More about the Abbott Volt PFA system
PFA uses high-energy electrical pulses to destroy cells, causing abnormal heart rhythms. The technology has generated great excitement in cardiology because it appears better able than RF ablation to irreversibly damage myocardial tissue without irreversibly damaging surrounding tissues.
However, first-generation PFA systems can require multiple ablations with the catheter placed in various locations to treat targeted tissue effectively.
Abbott says it designed Volt to address these limitations. It paired a balloon-in-basket catheter with the EnSite X EP heart mapping system. Ensite X helps physicians visualize and position tools like the Volt PFA catheter in the heart. Abbott said the design can lead to more accurate ablation procedures with physicians given a clearer indication to make improved contact with targeted heart tissue.
The system’s balloon feature allows for efficient energy transfer to tissue, improving how the catheter creates lesions. This stops the heart’s erratic signals, Abbott said. EnSite X guides physicians to precisely identify areas requiring ablation, allowing for more accurate catheter positioning. This enables a more efficient workflow and reduced radiation exposure for the patient.
“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,” said Dr. Christopher Piorkowski, chief medical officer of Abbott‘s electrophysiology business. “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.”