State of the Cardiac Ablation Market

Cardiac ablation is making headlines again, and again.

Especially in the treatment of atrial fibrillation (AF), we are witnessing a transformative shift in how new technologies are being utilized.

Over the past four decades, innovations in cardiac ablation have redefined the AF treatment landscape, offering safer and more effective options with improved outcomes.

This week, let's dive into the history of cardiac ablation, the drivers behind the adoption of new energy modalities, and the numbers that give insight into what the future may hold for this evolving market.

Brief History of Cardiac Ablation

For decades, radiofrequency (RF) ablation and cryoablation have dominated AF treatment.

Introduced in the mid?1980s and early 2000s respectively, these energy modalities transformed AF management by enabling electrophysiologists to precisely target and isolate arrhythmogenic tissue in the pulmonary veins.

• Radiofrequency Ablation: Harnesses thermal energy to create controlled lesions that disrupt erratic electrical signals. Although highly effective, it carries the risk of collateral damage to surrounding structures.
• Cryoablation: Uses extreme cold to freeze tissue, offering a different method of lesion creation. While it simplifies pulmonary vein isolation, it sometimes falls short in terms of precision and durability.

Now, a new era is emerging in cardiac ablation: pulsed field ablation (PFA).

A departure from thermal approaches, PFA utilizes non?thermal electric fields to selectively target cardiac cells while preserving the surrounding tissue.

Why Shift to PFA?

The rapid adoption of pulsed field ablation (PFA) is fueled by multiple compelling advantages over RF and cryoablation:

• Enhanced Safety: PFA significantly reduces the risk of damaging adjacent structures, such as the esophagus and phrenic nerve, addressing major concerns with traditional ablation methods.
• Faster Procedures: Early studies indicate that PFA can significantly shorten procedure times compared to RF and cryo, boosting efficiency in high-volume electrophysiology labs.
• Superior Efficacy: Promising durability in early clinical trials means fewer repeat ablations over time, especially notable when 20% to 40% of current catheter ablation patients require a second procedure.
• Regulatory Momentum: Major strategics are aggressively developing and acquiring PFA technologies, underscoring its potential to become the new industry standard.

With large-scale clinical trials underway and increasing regulatory approvals, PFA has all the tailwinds to overtake traditional ablation methods as the dominant technique for AF treatment.

The Numbers Behind This Market

According to LSI’s Global Surgical Procedure Volumes database, a trusted resource with coverage of 300+ diagnostic and therapeutic procedures in 12 major categories across 37 countries, approximately 1.4 million cardiac ablations were performed worldwide in 2024.

Across every cardiac surgery we track, cardiac ablation procedures are projected to grow at the fastest rate. From 2024 to 2029, we project global volumes of cardiac ablations will increase at a CAGR of 8.8%.

This growth rate is more than double the rate of global cardiac surgery volumes, which are increasing at a CAGR of 4.3% during the same forecast period.

As is often the case, with tremendous procedure growth comes tremendous market growth.

In 2024, the ablation market (including mapping systems) was valued at $6.4B. Fueled by next-generation devices that command significantly higher prices, this market is expected double in total value by 2030, growing at a CAGR of 9.8%.

For comparison, the total cardiovascular devices market is growing at respectable, yet slower CAGR of 5.8%.

This sets the table for understanding why so many companies, from startups to strategics, are actively pursuing the regulatory approval of PFA solutions.

Did you know that transcatheter technologies make up $24.7B of the $58.8B global cardiovascular market? Or that electrophysiology devices are the fastest-growing segment in cardiovascular, with an 8.3% CAGR?

LSI's Cardiovascular Market Intelligence Package can deliver answers on market size, trends, opportunities, key players, hot startups, funding activity, and factors fueling growth or decline.

Get access to LSI's Cardiovascular Market Intelligence Package

The State of the PFA Race

This emerging market opportunity has brought on a horse race like no other. We're closely tracking the status of PFA programs at major medical device companies

As of February 2025, here's the state of the race at a glance:

Boston Scientific

• The FARAPULSE? PFA System received FDA approval in January 2024.
• The system has now been used in over 200,000 patients worldwide.

Medtronic

• The company’s PulseSelect? PFA system received FDA approval in December 2023.
• The system completed its first commercial cases with the 10F FlexCath Contour? sheath in February 2024.

Johnson & Johnson MedTech (Biosense Webster)

• The VARIPULSE? PFA System, which integrates with the industry-leading Carto system, received FDA approval in November 2024.
• In January 2025, the company paused the External Evaluation cases of VARIPULSE? in the U.S. to investigate four reported neurovascular events. VARIPULSE? has been used in over 3,000 completed commercial cases.

Abbott

• The company has announced plans to launch Volt?, its first PFA device outside of the U.S. in 2025. As of January 2024, over 30 patients were treated in Australia as part of the system's CE Mark study
• The company plans to file an FDA submission sometime this year.

Emerging Players in PFA

Not to be eclipsed by corporate powerhouses, we’re also tracking a number of companies that are developing and seeking to commercialize their own ablation technologies, with aspirations to capture a piece of the total addressable market.

There are a number of exciting companies that are on our analyst team's watchlist. Through LSI's global partnering events (LSI USA, LSI Europe, LSI Asia), we have a front row seat to the leading innovators in medtech, and continue to track industry-wide private companies and deals in our Companies & Deals Database.

One company we're closely following; #LSIAlumni Healium Medical.

Healium Medical 's no-contact guided ablation technology allows simultaneous tissue ablation and lesion monitoring, featuring miniature transcatheter ultrasound technology.

As Healium's CEO Ran Sela explains, there are a common set of limitations that plague the current PFA systems, which they are aiming to address.

Currently, there are two main technological groups for ablation. The "point by point" and the "one shot balloon." They have three limitations in common. You have to make stable contact to ablate. It's not trivial to get good contact because the heart is moving and the patient is breathing. "Point by point" tends to leave gaps between lesion points, but even with a "one shot" we see in the anatomy that not all pulmonary veins were created equal. It's very difficult to create a circumferential lesion even with a "one shot" solution. And, neither of them have any integrated imaging. You don't know the lesion thicknesses, or what's happening to the tissue during ablation. It's basically done on physician experience and expertise....

With many companies pursuing PFA, Healium is evaluating the use of no-contact ultrasound ablation that combines continuous monitoring and imaging in a single system.

Our solution is different. We use a different energy modality to create the lesion effectively, and we use ultrasound. Our main building block for the technology is an ultrasound console, softer transducer motorized unit, and an ablation catheter.

The sweetener? The company is evaluating the technology for use in other indications, including hypertension (i.e., renal denervation), heart failure, tumor ablation, and lung denervation.

You can view Healium's full presentation in LSI's Video Library.

We're closely following a breadth of innovation in this space, with multiple other companies making waves and advancing novel solutions, including:

Kardium Inc.

• CEO: Kevin Chaplin
• Developing a complete solution that combines advanced mapping and single-shot pulsed field ablation (PFA) into a single catheter, consists of 122 electrodes in a spherical array that enables single-position pulmonary vein isolation.

Field Medical #LSIAlumni

• CEO: Steven Mickelsen
• Purpose-built system that incorporates PFA, contact force sensing, electromagnetic localization, and artificial intelligence-enabled mapping capabilities.

AtriAN Medical #LSIAlumni

• CEO & Co-founder: Ken Coffey
• Gentle energy, micro Pulsed Electric Fields (mPEF), to only ablate hyperactivity. The other tissues such as the myocardium are spared.

Impact for Patients

The adoption of PFA and other novel ablation technologies are significant advancements in AF care. Patients stand to benefit in several ways:

• Lower Complication Rates: Reduced risk of collateral tissue damage means fewer serious complications.
• Shorter Recovery Times: Faster procedures and reduced inflammation could translate to quicker recovery and shorter hospital stays.
• More Durable Outcomes: If PFA continues to demonstrate superior long-term efficacy, it could reduce the need for repeat procedures.

As these technologies continue to evolve, patient outcomes are expected to improve, making ablation an increasingly attractive alternative for those with symptomatic AF.

Ultimately, better interventions seek broader adoption of cardiac ablation. There are two ways that medtech companies seek to increase the eligible patient population:

1. Expansion into other types of AF patients. The current beachhead is patients with drug-refractory paroxysmal AF, with persistent AF
2. Approval as a first-line therapy. Boston Scientific is currently running the AVANT GUARD trial comparing PFA against anti-arrhythmic drugs.

The cardiac ablation market is in a period of rapid expansion, driven by rising AF Incidence, affecting 38 million people globally, with prevalence increasing due to aging populations and rising cardiovascular risk factors.

The energy modality is just one leg of this race. In such a competitive market with a dominant market leader (J&J), the success of future ablation systems will depend on the integration of advanced mapping and navigation solutions to further enhance procedure precision and efficiency.

The shift toward PFA and other next-generation ablation technologies represents a significant inflection point in AF care. The future of cardiac ablation will be defined by safer, faster, and more effective treatments, improving outcomes for millions of AF patients worldwide.

More From LSI Market Intelligence

• Want to connect with leaders like Chris Eso (Medtronic), Michael J. Ryan (Boston Scientific), Celine Martin (Johnson & Johnson), Lisa Earnhardt (Abbott) and more strategic leaders? They will be at LSI USA '25 in Dana Point on March 17-21, 2025. Secure your spot today while space is available.
• If you’re looking to keep up with funding in 2025, our Companies and Deals Database is your go-to resource. Stay on top of every Medtech transaction with 6400+ Medtech companies and their deals all in one place. Get started today and never miss a deal.

Until next week,

Henry Peck and Nicholas Talamantes

LSI Market Intelligence Platform

All data in this article is sourced from LSI's Market Intelligence Team