Recently, Kardium's pulsed field ablation (PFA) system—Globe—for the treatment of atrial fibrillation (AF) has received approval from the U.S. Food and Drug Administration (FDA). This move gives Kardium the green light to enter the emerging PFA field, allowing it to compete with industry giants such as Boston Scientific, Medtronic, and Johnson & Johnson.

It is reported that the Globe system is designed to achieve single-shot isolation treatment of the pulmonary veins flowing into the heart, which are the origin of most cases of irregular heartbeat (i.e., atrial fibrillation).

Once the catheter is in place, it expands into a sphere with a diameter of about three centimeters, easily conforming to the funnel-shaped opening of the pulmonary vein. The catheter surface is equipped with 122 independently controllable electrodes, which can record cardiac activity, measure tissue contact, and ultimately perform pulsed field ablation. This technology allows for the targeted disruption of myocardial cells before affecting other nearby tissues.

Image Source: Fierce Biotech

Earlier, in a U.S. clinical trial published by Kardium, the data was also impressive. The average time to isolate all four pulmonary veins with the catheter was about 25 minutes (with a total fluoroscopy time of approximately 5 minutes), and the procedure was claimed to have a 100% success rate without any device-related complications. One year later, 78% of the 183 treated patients had not experienced atrial fibrillation again.

In addition, this approval also includes the licenses separately obtained for its cardiac mapping software and other catheter components, which also helps to fully unlock Kardium's capital reserves. Kardium previously raised $250 million in venture capital in July, adding to the $104 million received in 2024, preparing for its commercial launch in the United States this year.

Regarding the approval of its blockbuster product this time, Kevin Chaplin, CEO of Kardium, expressed great pride: "The FDA approval of the Globe system is the most significant milestone in Kardium's development history. We are immensely proud of what our team has achieved, fulfilling our mission to develop the best treatment solutions for atrial fibrillation. The Globe system supports personalized, efficient, and effective atrial fibrillation treatment."

Moreover, it is reported that the company has been exploring the catheter's ability to perform both focal and linear ablation to expand its therapeutic scope. At the same time, they are studying whether it can be folded and redeployed into different heart chambers to treat atrial flutter (the second most common arrhythmia after atrial fibrillation).

Previously, following the U.S. launch of Johnson & Johnson's Varipulse pulsed field ablation (PFA) system by the end of 2024, the global PFA market temporarily formed a tripartite competition, with the PFA products from three major medical device giants each having their own advantages.

Medtronic

Medtronic's PulseSelect SystemDecember 2023Obtained FDA approval in the United States, and the product is alsoThe First PFA Product Approved in the U.S. Market, which can cause apoptosis of ectopic myocardial cells through bipolar and biphasic high-voltage electrical pulses while avoiding unnecessary damage to surrounding tissues, thereby preventing complications caused by traditional ablation methods.

In October 2024, another product of Medtronic – the Affera Radiofrequency Ablation System and Sphere-9 Catheter – received FDA approval for market release. With this, Medtronic not only has its own mapping system but also becomesThe First Company to Provide Two FDA-Approved PFA Systems for Treating AFib。

Boston Scientific

Boston Scientific's FARAPULSE Pulsed Field Ablation SystemApproved in January 2024It consists of three parts: the main unit FARASTAR, the ablation catheter FARAWAVE, and the sheath FARADRIVE. It can deliver pulsed electric field energy through the catheter to ablate cardiac tissue for the treatment of atrial fibrillation.

In July this year, Boston Scientific announced the latest news about its PFA system: the FARAPULSE Pulsed Field Ablation System received FDA approval for expanded indications.The system is now available for the treatment of drug-refractory, symptomatic persistent atrial fibrillation (AF)., breaking Medtronic's previous dominance in two indications and ending Medtronic's monopoly in this direction.

Johnson & Johnson

Johnson & Johnson's Varipulse Pulsed Field Ablation System Approved in ChinaNovember 2024, composed of the Varipulse ablation catheter and TRUPULSE generator. The ablation catheter was developed based on Johnson & Johnson's previous mapping catheter, the LASSO catheter, and is also a continuation of the LASSO catheter technology. Notably, within the PFA field, Johnson & Johnson has another major "trump card" — its already marketedLatest AI Cardiac Mapping System Carto 3, which is the 3D mapping system with the highest market share. Meanwhile, the Varipulse pulsed field ablation systemIs the first and onlyThe PFA technology integrated with Carto 3 is fully compatible with Carto 3, enabling an intuitive and reproducible workflow through real-time visualization and feedback mechanisms.

However, Johnson & Johnson's PFA product has faced a series of challenges after its market launch. It was suspended in the U.S. for over a month before resuming sales in February this year. Nevertheless, the uniqueness and cutting-edge technology of the Varipulse pulsed field ablation system remain irreplaceable. We look forward to seeing its outstanding performance in Johnson & Johnson's year-end financial report.

In addition, apart from the products of the three major giants—Boston Scientific, Medtronic, and Johnson & Johnson—multiple promising products are on the horizon in recent years, such as Field Medical, founded by Steven Mickelsen, the father of PFA, with its highly anticipated product.FieldForce™ Ablation SystemReceived FDA Breakthrough Device Designation by the end of 2024, and the product isCurrently the first and only PFA system specifically designed for ventricular arrhythmia ablation, is expected to lead the market.

In contrast, within China, a number of innovative medical device companies focusing on PFA have emerged in recent years, with many achievements already implemented. According to the Yaoke Medical Device Data query,Currently, more than 20 PFA series products have been launched in China.Among them, products from local innovative medical device companies such as Jinjiang Electronics, Denuo Electrophysiology, Huitai Medical, and Epert Medical have been approved for marketing. Currently, the proportion of domestically produced products has surpassed imported ones.

After the emergence of PFA products, the global electrophysiology market landscape has been completely transformed. With its new technology, PFA has carved out a new battleground within the electrophysiology field. It is predicted that by 2028, the global atrial fibrillation ablation market will double to reach 11 billion yuan. Of this, PFA’s market share in the atrial fibrillation ablation market will grow from less than 5% to over 60%. Based on this vast blue ocean market, major medical device companies are accelerating their innovative R&D efforts, and the electrophysiology market is set for new changes.