Cannibalization Foreseen Within the Electrophysiology Ablation Space

Pulsed-field ablation (PFA) is reshaping the electrophysiology landscape, potentially clouding the future of traditional ablation catheter treatment.

Boston Scientific Corp.’s Farapulse PFA system gained CE mark approval in 2021 and the product has experienced a 254% annual growth rate in patient treatments through 2023. PFA’s nonthermal, rapid lesion creation capability has earned it favor among European physicians, heralding potential cannibalization of traditional ablation catheters as PFA technology expands beyond Europe, according to GlobalData.
 
“PFA technology is only marketed in Europe, and yet, it has been dominating the electrophysiology market by storm,” GlobalData Medical Device Analyst Joselia Carlos said. “Based on KOL surveys conducted in Europe, most doctors are now preferring PFA catheters over other ablation catheters because of PFA’s ability to create lesions nonthermally and within milliseconds. GlobalData predicts product cannibalization amongst ablation catheters as PFA catheters become marketed in other regions besides Europe.”
 
Medtronic received a CE mark for its Affera Mapping PFA system in March 2023, and rival Biosense Webster also is developing its own PFA system—the Varipulse. Unlike Boston Scientific’s Farapulse and Medtronic’s Affera Mapping PFA systems, the Varipulse has not yet been approved (it is still undergoing clinical trials). 
 
“Interestingly, all three companies have reported that their PFA catheter will receive FDA approval, and therefore, will be marketed in the U.S. in 2024. It will be interesting to see whose PFA catheter will receive FDA approval first,” Carlos noted.
 
PFA catheters are typically used during electrophysiology procedures to treat atrial fibrillation (Afib). More recently, Boston Scientific’s Watchman FLX has also been dominating the Afib market. In 2022, the number of patients implanted with a Watchman FLX grew by almost 234%, compared with the number of procedures in 2018. Despite the Watchman FLX’s aggressive annual growth, the electrophysiology market still had the highest share in terms of the number of Afib procedures at 52% in 2022.
 
“Electrophysiology procedures remain the number one preferred treatment for Afib,” Carlos stated. “While the Watchman FLX has certainly shaken up the Afib market, PFA technology has solidified the electrophysiology space as the market leader within the Afib market. However, instead of gaining more shares within the Afib space, more ablation procedures will likely be performed with PFA in lieu of traditional ablation technologies.”