FDA clears Boston Scientific device for atrial fibrillation

The FDA has granted approval to a device made by Boston Scientific to treat atrial fibrillation, the company announced in a Jan. 31 news release.

The pulsed field ablation system, called FaraPulse, works by delivering non-thermal electric field pulses to gradually remove or ablate heart tissue while maintaining the health of surrounding tissues and structures. 

Traditionally, treatment for recurrent, symptomatic and intermittent atrial fibrillation relies on insertion of a catheter into the heart which creates extreme temperatures to kill areas that are causing abnormalities in the heart, but this procedure can be damaging to other tissue and areas around it. 

"A high bar has been set by performance of the system in clinical and commercial settings – where more than 40,000 patients have been treated to date – and we look forward to continuing to lead the way with this differentiated technology in the growing PFA space," Nick Spadea-Anello, president of electrophysiology at Boston Scientific stated in the release. 

With the FDA's approval, Boston Scientific now plans to "immediately launch the system in the U.S."

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