Shots:
- The US FDA has approved label expansion of Farapulse PFA System to incl. treatment of drug-refractory, symptomatic persistent atrial fibrillation (AF)
- Approval was backed by P-I data from the ADVANTAGE AF trial, which met safety & effectiveness endpoints in 260 pts intolerant to at least Class I/III anti-arrhythmic drug across 43 global sites; data was shared at AF Symposium 2025 & published in The JACC
- Also, Boston has initiated the ReMATCH IDE trial to evaluate the Farawave PFA catheter for posterior wall ablation & pulmonary vein isolation, & the adj. Farapoint PFA catheter for cavotricuspid isthmus & mitral isthmus ablation in ~375 pts with recurrent persistent AF post-ablation, across 40 sites in the US & Asia
Ref: Boston Scientific | Image: Boston Scientific| Press Release
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