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News & Trends - MedTech & Diagnostics

Abbott enters pulsed field ablation market: A new player among global medtechs

Health Industry Hub | February 7, 2024 |

MedTech & Diagnostics News: Abbott has made an entry into the pulsed field ablation market, standing alongside medtech competitors such as Medtronic, Boston Scientific, and Johnson & Johnson’s Biosense Webster.

Medtronic secured TGA listing of its PulseSelect pulsed field ablation (PFA) system in January of this year, making this the first PFA catheter to be commercially available in Australia. The system’s safety, efficacy, and efficiency is supported by the PULSED AF study, which showed a 0.7% safety event rate and clinical success rates of 66% in paroxysmal AF and 55% in persistent AF patients. J&J MedTech’s Varipulse PFA and Boston Scientific’s Farapulse PFA have yet to secure TGA approval, despite progress overseas.

Abbott has recently marked a milestone with the implementation of the first global procedures using the company’s Volt PFA System to treat patients with common abnormal heart rhythms, such as atrial fibrillation (AFib). Over 30 patients have been treated in Australia as part of Abbott’s Volt CE Mark study, a pre-market, multi-centre clinical trial designed to evaluate the safety and efficacy of the system.

Professor Prash Sanders, Director of the Centre for Heart Rhythm Disorders at the University of Adelaide, conducted the first procedures and expressed optimism about the innovative technology.

“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 capitalise on those potential benefits,” said Professor Sanders.

Abbott’s Volt system, designed to address the limitations of first-generation PFA systems, sets itself apart by combining a balloon-in-basket catheter with Abbott’s EnSite X EP System, a state-of-the-art heart mapping system.

Professor Sanders noted the unique design of the Volt system, especially when combined with the mapping system, stating that it “can address hard-to-treat irregular heartbeats with a level of accuracy and precision that’s never before been possible.”

Unlike traditional cardiac ablation procedures using radiofrequency (RF) or cryogenic ablation, which apply heat or extreme cold to destroy tissue responsible for erratic heart signals, the Volt PFA System utilises high-energy electrical pulses. This approach reduces the risk of damaging adjacent tissue, especially in patients with complex disease or anatomy.

Dr Christopher Piorkowski, Chief Medical Officer of Abbott’s electrophysiology business, emphasised the importance of timely treatment for AFib patients.

He stated “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.”

With upcoming procedures in markets across Asia Pacific and Europe, Abbott is also anticipating approval for its U.S. clinical trial (IDE) for the Volt system in the first half of this year.

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