The US FDA Grants Approval to Boston Scientific’s Farapulse Pulsed Field Ablation (PFA) System for Atrial Fibrillation (AF)
Shots:
- The Farapulse PFA System is approved to extract pulmonary veins for treating drug-refractory, recurrent, symptomatic, paroxysmal AF based on the 12mos. data from (ADVENT) study of the system vs SoC ablation
- The device demonstrated shorter ablation time and a fast-learning curve for physicians. The RWE from the MANIFEST-17K registry showed its real-world safety without permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury
- The system includes Farawave Ablation Catheter, Farastar Ablation Generator & Faradrive Steerable Sheath, accompanied by VersaCross Connect Access Solution, for safe access to the left side of the heart. It utilizes tissue-selective, non-thermal electric fields for heart tissue ablation thus preventing damage to surrounding tissues
Ref: Boston Scientific | Image: Boston Scientific
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
