핵심 개념
Farapulse PFA System approved by FDA for paroxysmal AF treatment.
초록
Boston Scientific's Farapulse PFA System gains FDA approval for treating paroxysmal AF, offering an alternative to thermal ablation. The system utilizes nonthermal electric fields for ablation, showing safety and efficacy in clinical trials and real-world data. The device is set to impact AF treatment positively, with ongoing trials and future developments enhancing its capabilities.
Key Highlights:
- FDA approves Farapulse PFA System for paroxysmal AF treatment.
- System uses tissue-selective, nonthermal electric fields for ablation.
- Positive results from ADVENT clinical trial and real-world data support system's safety and efficacy.
- Farapulse PFA System poised to change AF treatment landscape.
- Boston Scientific working on further developments and trials for the system.
통계
Positive 12-month data from the ADVENT clinical trial showed the Farapulse system was as safe and effective as conventional thermal ablation.
More than 17,000 patients in the MANIFEST-17K registry showed continued real-world safety of the system.
인용구
"Within the ADVENT clinical trial, the Farapulse PFA system was shown to be a safe, effective and efficient option for treating paroxysmal AF." - Vivek Reddy, MD