Dive Brief:
- Medtronic won Food and Drug Administration approval for its Affera mapping and ablation system for the treatment of persistent atrial fibrillation (AFib), the company said Thursday.
- Affera combines mapping technology with a catheter capable of performing radiofrequency (RF) and pulsed field ablation (PFA). The features set the device apart from Medtronic’s Pulseselect and Boston Scientific’s Farapulse, both of which are already on the market but only offer PFA.
- Stifel analysts said Affera is a “meaningful upgrade” over Pulseselect. One physician told analysts at Needham he expects his PFA mix to shift from 100% Farapulse to 50% Affera, 30% Farapulse and 20% Johnson & Johnson’s Varipulse as new devices come to market.
Dive Insight:
PFA is a new cardiac ablation technique to treat a common heart arrhythmia. Traditional ablation methods use heat or cold to scar heart tissue, blocking irregular signals, but PFA uses electrical pulses, reducing the risk of injury to surrounding tissue.
Medtronic’s single-shot Pulseselect system became the first FDA-approved PFA device in December 2023, but it lacks mapping capabilities or the option to deliver RF energy from the catheter.
Affera addresses those capability gaps. Medtronic closed a $925 million takeover of Affera and its cardiac ablation and mapping devices in 2022.
The wide area focal Affera Sphere-9 catheter can switch between RF and PF energy and is integrated with mapping technology. Until recently, physicians who wanted to map PFA procedures had to use systems from third parties, primarily Abbott and J&J. That has changed in the past week, with the Affera authorization coming days after Boston Scientific won FDA approval for its Farapulse mapping system.
The approvals could drive further changes to the electrophysiology market. So far, Abbott has identified the launches of PFA devices by rivals as a factor that has accelerated its growth, in part because of extra demand for its mapping technology. However, Abbott and J&J’s rivals now have mapping systems and, in Affera, Medtronic has a device that could be a threat to their RF businesses.
Affera could significantly impact point-by-point ablation procedures that are typically performed with RF energy, a field dominated by J&J and Abbott, Stifel analysts said in a note to investors.
The analysts said their due diligence shows “Boston's Farapulse uptake is broad-based,” but the design of the company’s catheter suggests it has a different optimal patient population than Affera. Farapulse is best suited to single-shot, de novo ablation, the analysts said, whereas Affera's point-by-point ablation is a better fit for other cases.
Needham analysts identified increased PFA competition as a potential threat to Boston Scientific in a note published last week. The analysts noted the potential for price pressure and, quoting the physician who expects to use Farapulse in 30% of PFA cases, said they “think it is inevitable” that Boston Scientific loses meaningful market share.
Boston Scientific is preparing to present PFA data in persistent AFib, the population in which Medtronic tested Affera, and has challenged the idea that dual energy ablation is more efficient. Brad Sutton, Boston Scientific’s chief medical officer for AF solutions, said at a Wells Fargo event in September, “I would bet that we're significantly more efficient with persistent application.”
The approval of Affera positions the market to decide which is the best approach but there may be a lag between the authorization and full competition. Medtronic, which is halfway through its fiscal 2025, expects Affera will make a “limited” contribution this financial year. CEO Geoffrey Martha said at a Wells Fargo event in September that fiscal 2026 is “where you'll start to feel the impact of Affera revenue ramp.”
Martha said Medtronic had “work to do” on supply but had made “breakthroughs on the manufacturing capabilities over the last couple of months, even weeks.” The complexity of manufacturing the catheters has been a talking point but Martha said that is a narrative pushed by Medtronic’s competitors.
