The Pulsed-Field Ablation Race Heats Up

The company received a CE Mark label expansion for its FARAPULSE platform, allowing the pulsed-field ablation system to treat patients with persistent atrial fibrillation (AFib). The approval covers the FARAWAVE and FARAWAVE NAV catheters and follows results from the ADVANTAGE AF clinical trial, where the technology met its primary safety and efficacy endpoints.

The update arrives at an important moment for pulsed-field ablation. The PFA market only began to take shape in 2024, yet competition has intensified quickly. Expanding indications represent one of the most direct ways for companies to grow their share of this rapidly developing market.

Before looking at how the competitive landscape is shifting, it helps to understand what the persistent AFib indication adds to the overall opportunity.

Expansion of the Addressable AFib Population

AFib affects an estimated 60 million people worldwide, according to the Global Burden of Disease study. Clinically, these patients are typically grouped into three categories based on how long the irregular rhythm persists:

  • Paroxysmal AFib involves sudden, temporary episodes that resolve on their own within 48 hours to seven days.
  • Persistent AFib refers to episodes that last longer than seven days and do not resolve on their own.
  • Permanent AFib represents a chronic rhythm disorder where the heart remains in AFib indefinitely.

Until this label expansion, PFA was indicated for paroxysmal AFib. Based on the results of the Realise AF survey, that’s only about 27% of patients who are eligible for a PFA procedure. According to the study, the AFib population breakdown is as follows:

  • Paroxysmal AFib: 26.5%
  • Persistent AFib: 23.8%
  • Permanent AFib: 49.6%

That last number is one worth sitting with; almost half of all AFib patients have permanent AFib, which is not currently eligible for ablation. However, adding persistent AFib nearly doubles the number of patients eligible for pulsed-field ablation therapy.

With this label expansion, Boston Scientific is now able to go after roughly half of the European market.

Market Size and Procedure Growth

The broader cardiac ablation market is already substantial.

LSI estimates that about 1.6 million cardiac ablation procedures are performed worldwide each year using radiofrequency, cryoablation, and pulsed-field ablation technologies.

Of those procedures, more than 300,000 are already performed using PFA.

In terms of market size, the market is valued at $6.5 billion. We’re looking at the sum of sales for all ablation devices, as PFA is having a cannibalizing effect on radiofrequency, and especially on cryoablation.

We’re looking at market growth in excess of 30%. With billions of dollars in device revenue and strong procedural expansion, it is no surprise that the competitive race is moving quickly.

This blog is originally published here: https://www.lifesciencemarketresearch.com/insights/the-pulsed-field-ablation-race-heats-up

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