“I’m thrilled to share that the novel Farapulse pulsed field ablation system has received approval in China! With 12 million people in China living with atrial fibrillation (AF), this approval marks our commitment to bringing the most clinically proven PFA system to physicians and their patients living with paroxysmal AF,” Nick Spadea-Anello, global president of Boston Scientific’s electrophysiology business, said in a LinkedIn post today.
“There is so much to look forward to as we increase access to the Farapulse PFA system around the world,” Spadea-Anello said.
The news comes nearly six months after Boston Scientific won FDA approval for the use of Farapulse in treating drug-refractory, recurrent, symptomatic, paroxysmal AFib. It became the second company to receive FDA approval for a pulsed field ablation (PFA) system that treats AFib after Medtronic.
Boston Scientific bought Farapulse for nearly $300 million in 2021 — the same year the system secured its CE mark in Europe.
PFA has generated great excitement in the cardiology space because, unlike the radiofrequency ablation systems out there, it is non-thermal. Its potential advantages versus RF ablation or cryoablation include the characteristic that heart muscle tissue can be especially susceptible to it. In contrast, other types of surrounding tissue are injury-resistant to PFA, a factor that could reduce complications.
Some companies have also bet on AFib-treating systems that toggle between PFA and RF. At our DeviceTalks Boston show in May, Spadea-Anello compared those systems to hybrid cars, while he said a pure PFA system such as Farapulse is like an electric car. He said Boston Scientific is betting that the future is heading toward pure PFA
The Farawave catheter can treat a range of pulmonary vein anatomies using an over-the-wire catheter with a variable basket and flower shapes. The design enables the device to adapt to individual patient anatomies.
“Unlike a lot of the competitors out there, Farapulse is unique in that it was designed from the ground up as a pulsed field ablation system,” Boston Scientific Chief Medical Officer Ken Stein told MassDevice early this year. “It’s not a repurposing catheter that was designed for something completely different. And it has well over a decade of preclinical experience and now clinical experience validating that we’ve got the right catheter design, the right waveform and an optimal dosing strategy.
