Boston Scientific aims to become the market leader in the electrophysiology category as the device maker looks to pulsed field ablation to drive growth.
“Our new vision is not just to be a leader in pulsed field ablation, but to be a leader in overall electrophysiology,” Nick Spadea-Anello, Boston Scientific’s global president of electrophysiology, said at a Tuesday investor meeting.
PFA is a minimally invasive procedure where tissue is selectively scarred to treat atrial fibrillation, a common heart arrhythmia. The technology is expected to outpace other types of cardiac ablation because it can reduce the risk of damage to surrounding tissue and shorten procedure times.
Competition in the category has grown quickly as Boston Scientific, Medtronic and Johnson & Johnson have launched PFA devices in the U.S. Abbott received Europe’s CE Mark earlier this year for its own PFA device, and the company hopes to receive approval in 2026.
Spadea-Anello said that Boston Scientific has an advantage in being the first company to bring a PFA device to market. The company received a CE Mark for Farapulse in 2021.
Boston Scientific has treated 500,000 people to date with its Farapulse PFA system, Spadea-Anello said.
“This is significantly more than any other offering, to the tune of hundreds of thousands of more patients,” he claimed.
Farapulse is the most prescribed PFA device, the executive added, and the company expects more growth as it adds new devices to its portfolio.
J.P. Morgan analyst Robbie Marcus wrote in a research note that with continued leadership in atrial fibrillation ablation, indication expansion, and product rollouts in mapping and intracardiac imaging, “we think market leadership over the next few years is within reach.”
Upcoming products, trials
Boston Scientific executives highlighted new ablation catheters and mapping tools that they plan to launch in the coming years. A PFA catheter, called Farapoint, that allows electrophysiologists to create focal and linear-shaped lesions, is expected to launch before the end of the year.
In 2027, Boston Scientific expects to launch a new version of its current Farawave PFA catheter. Spadea-Annello said the device will give physicians more information and precision, is more ergonomic and will feature enhanced contact sensing. In 2028, the company plans to launch a device called Faraflex, a large focal catheter that is designed for mapping and ablation.
Boston Scientific also highlighted three clinical trials featuring its Farapulse platform, testing the system as a first-line treatment for persistent atrial fibrillation, in redo ablation procedures and as a treatment for ventricular tachycardia, Stifel analyst Rick Wise wrote in a research note.
The company forecasts the global electrophysiology market to grow from an estimated $13 billion in 2025 to $20 billion in 2028.