Truist analyst Richard Newitter indicates that feedback from the Heart Rhythm Society (HRS) meeting suggests 50% to 70% of doctors will “immediately” adopt the technology.
New PFA Technology Leading AFib Treatment
At last month’s Heart Rhythm Society (HRS) annual meeting in Boston, analysts noted that doctors’ enthusiasm for the new pulsed field ablation (PFA) systems indicates a swift adoption of this treatment method, benefiting device manufacturers in bringing these products to market.
Pulsed field ablation (PFA) was a focal point at the conference. Citi Research analyst Joanne Wuensch mentioned in a report to clients on Sunday: “The amount of data and discussions about pulsed field ablation (PFA) was overwhelming, with doctors crowding in to see the latest data.”
PFA is a catheter-based cardiac ablation technology used to treat atrial fibrillation (AFib). It is seen as a safer alternative to traditional radiofrequency and cryoablation, effective in treating the most common form of arrhythmia (AFib). Shorter procedure times are considered another advantage.
Also known as irreversible electroporation, PFA is dependent on electric fields, non-thermal, highly penetrative, and long-lasting. It effectively addresses the “zero-sum effect” of thermal ablation, receiving favorable clinical research evaluations and promising to become a new option for AFib catheter ablation.
According to HRS, antiarrhythmic drugs are currently recommended as the first-line treatment for AFib but can cause adverse events. Unlike thermal ablation, which uses heat or extreme cold, PFA disables heart cells using electric fields.
HRS stated: “The latest advancements in catheter design and energy delivery can pave the way for wider clinical adoption of PFA to improve patient outcomes.”
Strong Market Reaction to PFA
Truist Securities analyst Richard Newitter reported that recent research data from Johnson & Johnson and Medtronic on PFA devices, along with a subset analysis of Boston Scientific’s Advent trial, largely validated the procedure’s safety and efficacy.
Newitter noted that electrophysiologists’ feedback indicates very rapid initial adoption of the technology, estimating that 50% to 70% of doctors will quickly adopt it. “Initial interest in PFA among U.S. doctors is very strong, and PFA usage is rapidly increasing.”
The analyst predicts that Boston Scientific will hold the largest early advantage in the U.S. PFA market, with Medtronic “quickly following suit.”
Boston Scientific’s Farapulse PFA device received FDA approval in January this year, while Medtronic’s PulseSelect was approved in December last year. Johnson & Johnson recently submitted an application for its Varipulse platform to the FDA, and Abbott is also developing a device named Volt.
Stifel analyst Rick Wise emphasized that PFA consistently reaffirmed its promise of safer, faster procedures at the HRS meeting. Wise wrote to clients: “At HRS, comments from both doctors and companies clearly indicated that the adoption of pulsed field ablation (PFA) is happening faster than expected.”
The analyst added that due to strong demand from doctors and lower sensitivity to price, PFA adoption in the U.S. is much faster than in Europe.
As PFA took center stage at the HRS meeting, leading medical technology companies are introducing devices in the U.S. The next market developments include the FDA’s upcoming decision on Johnson & Johnson’s Varipulse system and how quickly Abbott can submit its device for FDA review.
Related Chinese PFA Manufacturers
Data shows that in 2023, radiofrequency ablation accounted for 88% of AFib ablation procedures in China, with cryoablation making up the remaining 12%. PFA is expected to be commercialized in China within two years. By 2028, the number of AFib ablation procedures in China is projected to reach 590,000, with PFA procedures accounting for approximately 9%.
Several Chinese companies have been developing PFA devices in recent years, with some products approved by the NMPA or patented. Here are ten domestic PFA companies in China:
- Acotec
- Dinova
- Shenyue Medical
- Jinjiang Electronics
- Yuanshan Medical
- Zhoulian Medical
- MicroPort EP
- Huatai Medical
- Xintong MedTech
- HeartCare Medical
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