Boston Scientific collected a set of FDA green lights for an update to its pulsed field ablation system for atrial fibrillation, allowing it to combine cardiac mapping sensors and therapy delivery in a single catheter.
The Farawave Nav probe adds magnetic navigation capabilities to help minimize the need for swapping out devices during a procedure with the company’s Farapulse ablation platform—which Boston Scientific said has already been used to treat more than 125,000 patients with intermittent afib worldwide, since its commercial debut at the top of this year.
The FDA handed down a premarket approval for the Farawave Nav as well as a 510(k) clearance for the paired Faraview mapping software, which visualizes the star-shaped catheter’s placement and orientation within the heart in real time. Both systems are compatible with the company’s Opal HDx mapping platform.
The Faraview software also tracks where ablation has been applied within the heart muscle, as well as how much, through a cumulative view and automated tagging within the image. The company said incorporating mapping and navigation would also help reduce the use of X-ray fluoroscopy.
A clinical trial to study the combined system was launched this past April—both in the indications of intermittent or paroxysmal afib, where Farapulse has been approved by the FDA and in persistent afib, where Boston Scientific is planning to expand. The company reported that it completed its final case, out of about 30 participants in Europe, in early July.
Pulsed field ablation aims to deliver the same results as traditional radiofrequency-powered or thermal ablation—while avoiding the potential of damaging nearby healthy tissues and sparing patients potentially dangerous side effects—by relying on tuned electric fields that disrupt the membranes of certain cells more than others, such as the ones that help govern heartbeats in cardiac muscle tissue and pulmonary veins.