Dive Brief:
- Physicians have used Abbott’s pulsed field ablation (PFA) device to treat more than 30 patients, marking the start of clinical development of a late challenger for a hotly contested market.
- Abbott expects to receive approval to study its Volt device in the U.S. in the first half of the year. Based on the timeline, RBC Capital Markets analysts predicted in a Thursday note to investors that Volt could launch in the U.S. as early as 2026.
- By then, Boston Scientific, which is poised to compete with Medtronic and Johnson & Johnson for the market, expects PFA to account for around half of atrial fibrillation (AFib) ablation revenues, but Abbott foresees a more gradual shift.
Dive Insight:
Multiple large medical device companies are working to get PFA devices to market. The systems are used to treat the millions of people affected by AFib, the most common type of irregular heartbeat.
Stifel analysts see PFA devices as a threat to Abbott’s $1.9 billion electrophysiology business. Believing devices from Medtronic, which won approval last month, and Boston Scientific, which is forecast to win approval this quarter, will quickly win market share from products that use temperature to ablate tissue, the analysts predicted in June that 90% of Abbott’s electrophysiology sales could be affected by 2025.
Abbott’s belief that PFA will have a smaller impact, at least in the near term, reflects its perceived shortcomings of the first-generation devices. The company said in a Thursday press release it designed Volt to address the limitations, including by giving physicians a clearer indication of contact between the catheter and the targeted tissue.
Physicians in Australia have now used Volt to treat more than 30 patients. Volt has a balloon-in-basket catheter, a feature that RBC analysts said offers “ease of use,” and is connected to Abbott’s Ensite X EP heart mapping system. The features are intended to improve contact with targeted heart tissue and enhance the creation of lesions that stop heart rhythm disorders.
Abbott expects to win approval to run a clinical trial in the U.S. in the first half of the year. RBC analysts estimate the study could start five to 13 months after approval, enroll 300 to 600 participants and follow subjects for up to one year. Those figures, and an anticipated lag of eight to 13 months between study completion and device approval, led the analysts to predict Volt could launch in the U.S. in 2026.
The analysts expect Volt to launch in paroxysmal AFib, with approval in the persistent form of the heart rhythm disorder following a year later. With Medtronic already on the market, Boston Scientific close behind and J&J scheduled to complete its trial this month, Abbott looks set to cede a head start of several years to its rivals.
Abbott expects “economics, lack of long-term results and limited use for paroxysmal Afib only” to slow uptake of the rival devices, RBC analysts wrote, and “doesn’t see a scenario where catheter integration by competitors would drive pull-through to their mapping systems, given the cost involved.”
In October, Abbott CEO Robert Ford predicted the electrophysiology unit would “grow generally in line with market” in 2024 and outlined areas where he sees PFA having limited impact.
“[PFA is] a product that's going to be really geared towards AF ablations. You still have [ventricular tachycardia] and [supraventricular tachycardia] ablations, where we do have good positions,” Ford said. “A good portion of our sales are also on the mapping side and ... the diagnostics and those consumables. I see those being less impacted also.”
