Dive Brief:
- Boston Scientific has received Food and Drug Administration approval for a new pulsed field ablation catheter that is indicated for use as an adjunctive device in a type of ablation that is performed when treating persistent atrial fibrillation.
- Called Farapoint, the device can deliver linear and focal lesions across complex heart anatomies in a single catheter while preserving surrounding cardiac tissue, the company said in an emailed statement Tuesday. The catheter can be combined with the company’s Faraview software module on the Opal HDx mapping system to enhance visualization of the catheter and lesion formation.
- Boston Scientific said clinical data supporting the approval, in cavotricuspid isthmus ablation, demonstrated the device was safe and effective, and showed high effectiveness in preventing atrial flutter recurrence.
Dive Insight:
Boston Scientific’s Farapulse system has remained the leading PFA technology since its introduction in Europe in 2021 and U.S. launch in 2024.
PFA, which delivers energy pulses to the cardiac tissue to disrupt the abnormal electrical signals that cause AFib’s irregular heartbeats, is quickly transforming treatment of the condition, and Medtronic, Johnson & Johnson and Abbott have all rolled out competing systems.
Persistent AFib, which accounts for about 25% of all AFib cases according to Boston Scientific, is a rapid heartbeat that lasts for seven days or more and can lead to complications such as blood clots, stroke and heart failure.
Stifel Research analyst Rick Wise said the arrival of Farapoint, which has also obtained the CE mark in Europe, could help Boston Scientific generate greater revenues per procedure and increase or sustain its overall electrophysiology market share.
The line ablations enabled by the device are also performed in “re-do” AFib procedures, which Stifel estimated make up about 40% of all AFib ablation procedures.
“Farapoint complements Boston's market-leading, larger footprint/single-shot Farawave catheter,” Wise wrote Tuesday in a note.
In a presentation at the J.P. Morgan Healthcare Conference Tuesday, Boston Scientific executives said Farapoint is in a limited market release in Europe and will be scaling up quickly over the course of this year. The company is also studying use of the device in re-do procedures and in ventricular tachycardia in clinical trials.
