A new treatment paradigm for atrial fibrillation (AF) is on the horizon in the form of pulsed field ablation (PFA).

The technology is earmarked as an advancement over its counterpart – thermal ablation – in the treatment of the heart rhythm condition that affects around 59 million individuals worldwide.

Two recent high-profile approvals by the Food and Drug Administration (FDA) mean the technology is now available in the US. Medtronic’s PulseSelect became the first PFA device approved in the region, with Boston Scientific’s Farapulse following suit just a month later.

Unlike heat – or cold energy in the case of cryoablation – PFA uses short bursts of electrical energy to kill off heart tissue associated with AF.

The procedure, which produces the same efficacy but with improved safety, seems to be delivering on its promise to transform AF care. How will the fertile US market play out with the new technology, and are there pricing hurdles to its rollout?  

Market outlook

While Europe has had PFA systems since 2021 – Medtronic, Johnson & Johnson (J&J), and Boston Scientific all have systems marketed in the regions – the US only received its first regulatory late last year.

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Medtronic’s monopoly lasted one month in December, after which Boston Scientific joined the PFA arena. Both systems have enjoyed a swift uptake, though analysis by GlobalData shows that Boston Scientific’s Farapulse is enjoying a better market share.

GlobalData medical analyst Joselia Carlos said: “Medtronic’s PulseSelect System and Boston Scientific’s Farapulse System are currently the only two PFA catheters that are commercially available in the US. Sales for both products did not start until February 2024—despite the PulseSelect receiving FDA approval one month earlier than the Farapulse. Even so, physicians are showing a stronger preference for the Farapulse over the PulseSelect.”

Why has Farapulse performed stronger than its Medtronic competitor? Carlos says this is due to Farapulse being the first PFA catheter to be commercialised in Europe, meaning physicians are likely more familiar with the device since it has been on the market longer. Additionally, research indicates the Farapulse System trials appear to produce better outcomes than the PulseSelect trials, Carlos remarks. Data, however, is still at a relatively immature stage, so longer trends will need to be analysed.

The US market value of Boston Scientific’s Farawave, which is the catheter itself in the Farapulse system, almost tripled between February 2024 and March 2024, according to analysis by GlobalData. Unlike the declining trend of the regular electrophysiology devices, the prices of Farawave slightly increased, by 1.2% in the same period, analysis shows.

The electrophysiology device market in general paints a similar picture. Since Farapulse debuted, Boston Scientific has gained a large portion of shares in the sector, according to GlobalData market analysis.  

Europe remains a useful indicator of how the US market will react going forward. Ablation procedures across all systems in the latter continent have swayed considerably towards PFA due to the lower incidence of thermal injury to tissues beyond the myocardium. Electroporation, the energy delivery used in PFA procedures, appears to limit collateral damage.

Carlos remarks: “PFA has already cannibalised the electrophysiology ablation space in Europe since receiving the CE mark in 2021. According to primary research conducted on European electrophysiologists, PFA technologies are used in over 50% of electrophysiology ablation procedures. This same trend is expected to occur in the US as well.” 

As with all competitive markets, trends are also susceptible to activity by new joiners. J&J holds the top spot in the electrophysiology device market, possessing 54% of the market share. Boston Scientific, meanwhile, currently has 9%.

J&J’s Biosense Webster received approval for its PFA system Varipulse in Europe earlier this year. A month later, the company revealed it had filed for FDA approval. The PFA market, it seems, is set to become even more crowded.

 “J&J is a company that constantly innovates and is aware of the current trends,” says Carlos. “Unsurprisingly, J&J has its own PFA system. Receiving FDA approval for its Varipulse System will solidify its position as the market leader in the electrophysiology market.”

Space for disruptive technology

As with many new technologies, unique products that distinguish themselves from those of the big players will also shape the field’s future.

“I think it’s going to be an interesting business case study in a few years, looking at how the key players made their moves. These devices still have drawbacks, and we have a disruptive technology that does not fit into the current categories,” says Kevin Chaplin of PFA startup Kardium.

Kardium has already made waves in the PFA space with its device, currently in clinical trials, having netted over $104m in financing earlier this year. The company has developed a 122-electrode array that is truly a “one shot” catheter, overcoming the multiple applications needed with current systems. Kardium’s approach has been shown to isolate the pulmonary vein in 100% of cases, as per research presented in May at this year’s Heart Rhythm Society’s annual meeting.

Also in the space is Field Medical, which commenced first-in-human trials for its PFA system in the same month Kardium revealed its results. Field Medical is designing its PFA system for the treatment of life-threatening ventricular arrhythmias such as ventricular tachycardia (VT) and premature ventricular contractions (PVCs).

“It’s a huge market with tremendous growth opportunities. There are predictions that the market is going to shift to over 75% PFA catheters within less than three years. So, there’s a big shift happening, primarily due to the safety and the speed of the procedures,” Chaplin added.

Pricing concern

As PFA uptake spreads through the US electrophysiology sector, questions have arisen over reimbursement consistency for providers and coverage policy from payors. PFA systems are currently covered under current procedural terminology (CPT) code 93656, part of the intracardiac electrophysiological procedures range.

The Heart Rhythm Society has raised concerns about PFA payment coverage. In February 2024, its committee stated that “providers may face challenges with payment coverage of ablation procedures using PFA, with some commercial payors recently announcing PFA as “experimental or investigational” and, therefore, not medically necessary for various uses.”

In addition, the society said that the costs of PFA systems are high as with many other new technologies, which could influence coverage decisions by some payors.

Kardium CEO Kevin Chaplin said: “I personally don’t see any challenges in that area, reimbursement is already in place, that’s well established, and doctors are switching the technology they use once it’s improved, so they get the same reimbursement, whether it’s radiofrequency, PFA, or cryoablation.”

Chaplin predicts that Boston Scientific, Medtronic and eventually J&J will start to potentially pursue alternative reimbursement codes. However, he added that Kardium’s financial modelling is built on the existing reimbursement framework.

Carlos says the average selling price (ASP) for PFA is approximately $2,000-$3,000 more than the average ablation catheter, adding that its ASP is similar to that of laser ablation catheters.

“Interestingly, unlike laser ablation, physicians are willing to pay more for PFA catheters, most likely because PFA procedures are associated with lesser adverse events and shorter procedure times,” Carlos remarks.

The high ASP may not be an issue in the future in any case. GlobalData medical analyst Tina Deng predicts that prices will soon start to decrease.

Deng comments: “Companies may lower prices in the next five years to attract more users and gain market share, especially if a new product from a competitor demonstrates superior performance or features.”