For the $8bn global AF market, the most important technology updates come from podium presentations at global industry congresses throughout the year. Over the last few years, the most prevalent topic discussed at the podium has been Pulsed Field Ablation (PFA). This article summarizes the current competitive landscape and provides updates on data presentations from recent congresses.
What is PFA?
PFA is the first new energy source for cardiac ablation in over a decade. PFA technologies apply direct electric current and create lesions through irreversible electroporation. Details on the mechanism and potential benefits are outside the scope of this article - for more information, please see the article by Dr. Atul Verma et al., entitled “Primer on Pulsed Electrical Field Ablation: Understanding the Benefits and Limitations.”
Current PFA Competitive Landscape
In Europe, three PFA systems have received regulatory approval, with the Boston Scientific (BSX) FARAWAVE catheter first receiving CE Mark in January 2021. Recently, PFA systems from Galvanize Therapeutics and Medtronic have also been approved in Europe. The Medtronic PulseSelect catheter is expected to be the first system to receive U.S. FDA approval later this year or early 2024.
Many more PFA systems are in development at both strategic companies and start-up companies. In 2023 alone, thirteen new PFA catheters have been presented at the podium for the first time, as summarized in Table 1. There are additional catheters in development beyond this list, as some were presented in prior years, and some have not yet been presented publicly.
Recent PFA Data Presentations
The first industry congresses of 2023 have featured a number of key data presentations on PFA technologies. The four most impactful data sets are summarized in Table 2, and they include the first ever report from an IDE trial (PULSED AF), two large first-in-human trials (inspIRE and Medtronic Sphere9), and a FARAWAVE commercial registry from Europe (MANIFEST PF). All trials have also been published online, and you will find links to each publication at the end of this article.
Beyond the four trials mentioned above, over a dozen sites in Europe have presented results on their commercial experience with BSX FARAWAVE. The European Heart Rhythm Association (EHRA) congress featured the largest volume of data reports, with at least ten centers across Europe presenting data.
At the recent Heart Rhythm Society (HRS) congress, PFA was again the most prevalent topic at the podium, and three Late Breaking Clinical Trials (LBCTs) featured PFA. Overall, the data presented at HRS were not as impactful as previous data sets, but the highest-profile LBCT was the EU-PORIA registry presented by Dr. Boris Schmidt. Although not explicitly stated, it appears most, if not all, of the EU-PORIA cases, would have been included in MANIFEST-PF, and the efficacy results from both registries were very similar, 74% in EU-PORIA vs. 78% in MANIFEST.
For a broader overview of companies in the AF space with the strongest podium presence at HRS, please see our “PodiumShare” analysis below, which is published as part of each congress report from AFME, LLC.
What's Next for PFA?
With all the PFA presentations so far in 2023, one critical gap remains – there are no data yet from a prospective, randomized controlled trial. Thankfully, we do not have to wait long! The ADVENT trial sponsored by Boston Scientific is the U.S. IDE trial for FARAWAVE. Over 600 patients were enrolled and randomized to treatment with PFA vs. thermal energy, including both RF and cryo. Results are expected later this year, and the likely venues for presentation are European Society of Cardiology (August 25-28 in Amsterdam) or American Heart Association (November 11-13 in Philadelphia).
For complete updates on ADVENT and all other events at major EP congresses, please visit our website and subscribe to the “AF Podium Connection” service.
List of 2023 Key Publications on PFA
Ryan Bachman, CFA
Founder & President of AF Market Experts, LLC
Ryan is an EP industry veteran, having spent 12 years at Biosense Webster (BWI) in Global Strategic Marketing. At BWI, Ryan held various roles of increasing responsibilities, and across all roles, he led the competitive intelligence function, responsible for collecting, analyzing, and reporting market insights from all publicly available sources. For EP industry congresses, Ryan led all competitive intelligence activities and presented daily updates to company attendees at the event. In his most recent role, Ryan led the BWI Strategic Planning process, which involved an annual environmental scan analyzing not only competitive updates but also trends across the AF market. These collective market insights were then utilized to generate actionable strategic recommendations for the business. Prior to BWI, Ryan was an Associate Analyst for four years covering the medtech sector on two different equity research teams.
He recently founded AF Market Experts, LLC to deliver timely and thorough insights on the AF market from the most valuable source: global industry congresses. In addition to AFME, Ryan currently serves as the CFO for CHART Healthcare Academy.
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