Sam Brusco, Associate Editor01.18.24
Abbott revealed that the first global procedures have been completed using its new Volt pulsed field ablation (PFA) system to treat common abnormal heart rhythms like atrial fibrillation (AFib).
More than 30 patients were recently treated in Australia as part of the company’s Volt CE mark study. Abbott has upcoming procedures in Asia Pacific and Europe, and anticipates approval for its U.S. investigational device exemption (IDE) clinical trial for Volt in H1 2024.
Abbott’s Volt PFA system pairs its balloon-in-basket catheter with its EnSite X EP heart mapping system so physicians can visualize and position the Volt PFA catheter in the heart. The company said Volt’s design can being about more accurate ablation procedures because it offers a clearer indication to make improved contact with targeted heart tissue, because of the catheter’s positioning, handling, and steering.
Its balloon feature provides efficient energy transfer to tissue, in order to improve how the catheter creates lesions to stop erratic heart signals.
"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 Christopher Piorkowski, MD, 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."
Historically, patients requiring a cardiac ablation procedure to treat AFib received radiofrequency (RF) ablation, which uses heat to destroy tissue responsible for erratic heart signals, or cryogenic ablation, which freezes tissue. Instead of heat or extreme cold, pulsed field ablation uses high energy electrical pulses to destroy the cells causing abnormal heart rhythms, which can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy.
"We have long known that pulsed field ablation could open up an entirely new frontier in how we treat people battling the most complex cardiac arrhythmias. But like any innovation, early solutions have not been able to fully capitalize on those potential benefits," said Professor Prash Sanders, M.B.B.S., Ph.D., director of the Centre for Heart Rhythm Disorders at the University of Adelaide in Australia, who conducted the first procedures with Volt PFA. "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."
Earlier this month, Boston Scientific began the AVANT GUARD clinical trial for its Farapulse PFA system.
More than 30 patients were recently treated in Australia as part of the company’s Volt CE mark study. Abbott has upcoming procedures in Asia Pacific and Europe, and anticipates approval for its U.S. investigational device exemption (IDE) clinical trial for Volt in H1 2024.
Abbott’s Volt PFA system pairs its balloon-in-basket catheter with its EnSite X EP heart mapping system so physicians can visualize and position the Volt PFA catheter in the heart. The company said Volt’s design can being about more accurate ablation procedures because it offers a clearer indication to make improved contact with targeted heart tissue, because of the catheter’s positioning, handling, and steering.
Its balloon feature provides efficient energy transfer to tissue, in order to improve how the catheter creates lesions to stop erratic heart signals.
"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 Christopher Piorkowski, MD, 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."
Historically, patients requiring a cardiac ablation procedure to treat AFib received radiofrequency (RF) ablation, which uses heat to destroy tissue responsible for erratic heart signals, or cryogenic ablation, which freezes tissue. Instead of heat or extreme cold, pulsed field ablation uses high energy electrical pulses to destroy the cells causing abnormal heart rhythms, which can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy.
"We have long known that pulsed field ablation could open up an entirely new frontier in how we treat people battling the most complex cardiac arrhythmias. But like any innovation, early solutions have not been able to fully capitalize on those potential benefits," said Professor Prash Sanders, M.B.B.S., Ph.D., director of the Centre for Heart Rhythm Disorders at the University of Adelaide in Australia, who conducted the first procedures with Volt PFA. "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."
More on Pulsed Field Ablation Technologies
Last month, the FDA issued its first approval for PFA technology, Medtronic’s PulseSelect PFA system.Earlier this month, Boston Scientific began the AVANT GUARD clinical trial for its Farapulse PFA system.