Pulsed field ablation (PFA) is a treatment for atrial fibrillation, an irregular heartbeat disorder that can lead to blood clots in the heart and increase the risk of developing other heart problems. PFA has a lower chance of damaging surrounding structures than previous methods. It uses electrical pulses for a targeted approach at destroying abnormal tissue. PFA revenue exploded in the first quarter (Q1) of 2024 following the US Food and Drug Administration (FDA) approvals of Boston Scientific’s FARAPULSE and Medtronic’s PulseSelect. Over the last year, the PFA market has grown to over $500m, reveals GlobalData, a leading data and analytics company.    

In Q4 2024, Medtronic launched its new PFA device, Affera Sphere-9, after receiving FDA approval in late October. In its first month, Sphere-9 made about half of the revenue that FARAPULSE made in its first month after approval, according to GlobalData’s US Healthcare Facility Invoicing Database. In December, two months after approval, Sphere-9's revenue was at about a quarter of FARAPULSE’s revenue at the same point in its launch cycle.   

Medtronic’s Sphere-9 launched at a lower price than Boston Scientific’s FARAPULSE originally did. It appears that Medtronic is intending to be price competitive with Boston Scientific in order to gain market share. 

Boston Scientific and Medtronic are currently the two major players in the PFA market. Boston Scientific dominated the market with the release of FARAPULSE in Q1 2024, despite PulseSelect’s earlier approval.   

Despite accumulating less revenue than FARAPULSE, Sphere-9 doubled its sales in the second month after its launch. GlobalData notes that Medtronic is threatening to take market share from Boston Scientific if it can build on its current momentum, but the situation may be complicated by new players such as Johnson & Johnson’s Varipulse, which has the potential to shake up the market.