- Boston Scientific has reset expectations for the approval of its Farapulse pulsed field ablation (PFA) system, pulling the anticipated decision date forward to the first quarter of 2024.
- In October, Boston Scientific told investors to expect the Food and Drug Administration to approve the device in the second half of 2024. An earlier approval will end Medtronic’s brief PFA monopoly and clear Boston Scientific to start selling a device that is central to its growth plans.
- Truist Securities analysts wrote in a note to investors that a first-quarter approval for one of Boston Scientific’s “most important new product categories” would increase their confidence in the company’s potential for sales growth of 10% or more.
Evidence that PFA could be a safer way to treat the millions of people in the U.S. with atrial fibrillation (AFib) has fueled predictions that the technology will rapidly replace existing heat-based approaches. The scale of the opportunity has attracted companies including Medtronic, which won the first FDA approval late last year, Boston Scientific and Johnson & Johnson.
Boston Scientific presented pivotal data on Farapulse in August, providing the foundation for a filing for FDA approval. By October, the company had completed its submission to the FDA and was expecting to receive a decision in the second half of 2024.
Management updated the timeline in late December, telling investors a decision is now due in the first quarter.
Truist analysts previously forecast high-single-digit growth at Boston Scientific in 2024, rising to a “sustainable 10%+ growth rate” in 2025 and beyond. Early approval could pull forward the contribution for one of Boston Scientific’s “most important new product categories — increasing our confidence in [double-digit revenue] growth potential and upside to our margin/ EPS estimates,” the analysts wrote.
The analysts expect PFA to grow from less than 5% of the $5 billion AFib ablation market today, to 40% to 60% of an $8 billion market in 2026. Boston Scientific and Medtronic may have a duopoly over that time, with the Truist analysts forecasting additional competitors will come to market in 2026 or later.
The impact of an early approval on Boston Scientific will depend on its supply chain. In an October earnings call, Boston Scientific CEO Michael Mahoney told investors the team “has done a terrific job over the past 18 months in building supply of both catheters and the capital equipment needed,” adding that the company had “really significantly improved [its] supply capabilities” and would “be ready for the U.S. launch.”
At that time, Boston Scientific expected to launch in the U.S. in the second half of 2024. While noting Mahoney’s comments, analysts at BTIG wrote in a note to investors that they are waiting “for more detail on the initial pace of the commercial rollout following the pull-forward in approval timing.”
Boston Scientific disclosed the new timeline in a statement about the start of a clinical trial of Farapulse as a first-line treatment for persistent AFib.
Meanwhile, Pulse Biosciences shared an update Tuesday on getting its own PFA device to market. The company has filed for 510(k) clearance of CellFX nsPFA Cardiac Clamp, a surgical AFib device. Pulse Biosciences plans to compete with AtriCure and Medtronic for the surgical AFib market before expanding into the larger catheter delivery sector.