Recently,Abbott announced that it has begun using itsVoltPulse Field Ablation (PFA) System Performs First Human Surgeries.It is reported that the system, combined with its EnSite X cardiac electrophysiology mapping system, was clinically studied in more than 30 patients in Australia.

The company said that it plans to test the device in other markets in the Asia-Pacific region and Europe in the future, and take steps to obtain CE mark approval. Abbott noted that it is expected to receive approval for U.S. clinical trials in the first half of this year.

It is reported that cardiac electrophysiology ablation procedures can be divided into different types based on the energy used.Radiofrequency Ablation, cryoablation, and pulsed electric field ablation. Among them, radiofrequency ablation uses thermal effects to ablate myocardial cells; cryoablation induces apoptosis of myocardial cells through freezing. Both methods utilize heat conduction effects to achieve treatment and are also known as the "Song of Ice and Fire" in the field of atrial fibrillation ablation.

Pulse field ablation involves designing an appropriate pulsed electric field and using multiple short-duration, high-voltage electrical pulses to deliver ablative energy. This makes the ablation process non-thermal (without Joule heating), effectively inducing electroporation in myocardial cells, allowing extracellular ions to enter the cells. When a high concentration of Ca2+ enters, myocardial cells undergo fragmentation and die.

Unlike traditional thermal ablation techniques, pulsed field ablation delivers electrical pulses without generating excessive radiofrequency or cryogenic energy, thereby reducing some potential complications associated with traditional treatment methods, such as damage to surrounding nerves and blood vessels or risks to adjacent organs (e.g., the esophagus). The goal of this technology is to provide a safer and more effective cardiac treatment method, especially for arrhythmias like atrial fibrillation (AF).

Abbott Volt Pulsed Field Ablation (PFA) System

Abbott's Volt system uses a balloon basket catheter design to help deliver energy to heart tissue, while EnSite X can assist surgeons in accurately positioning the catheter within the heart, reducing the need for X-ray radiation exposure and real-time image guidance.

Christopher Piorkowski, Chief Medical Officer of Abbott's cardiac electrophysiology business, said in a statement: "For the millions of people living with atrial fibrillation, daily life can be challenging as symptoms often include palpitations, shortness of breath, dizziness, and chest pain, making it crucial for doctors to address the issue as soon as possible."

"As the number of AFib cases is expected to continually rise, Abbott’s Volt PFA system meets the growing need for more innovative solutions that can reduce patients' procedure times and overall hospital stays, allowing them to return more quickly to fuller, longer lives," Piorkowski added.

Currently, companies both in China and overseas have rushed to compete in the field of pulsed electric field ablation.

Last month, Medtronic, through itsPulseSelectHardware Receives FDA's First Approval for Pulsed Field Ablation System.Prior to this, the company had obtained the CE mark for PulseSelect and its dual-use Affera catheter, which can deliver both pulsed field and radiofrequency ablation.

Meanwhile, Johnson & Johnson's Biosense Webster division recently received approval in Japan for its Varipulse platform., the platform and its Carto3D HeartCombined with the mapping system. The system is currently under review in Europe.

Moreover, Boston Scientific stated that it expects to receive FDA approval for its Farapulse catheter by the end of March.The device received CE mark approval in early 2021, and not long after, Boston Scientific acquired Farapulse and its namesake developer for $295 million, concluding a long-standing collaboration.

Notably, pulsed field ablation is not exclusively the domain of the largest medical technology companies: startups have also been actively developing new methods, expecting them to grow into a multi-billion-dollar market in the coming years.

Supported by the Ajax Health incubatorCortexAnnounced at the end of last year the receipt of a $90 million financing commitment, the company is developing an integrated system that can both diagnose and treat arrhythmia.

Field Medical, launched in 2022 by one of the former founders of Farapulse, secured $14 million in seed funding last September.

With the entry of Abbott, the pulsed ablation market has already formed a landscape dominated by giants, with fierce competition among leading players. Looking ahead, how will these giants capture the market? Medical Device Frontline will continue to monitor.

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