Johnson & Johnson MedTech Reports the US FDA’s Approval of VARIPULSE Pulsed Field Ablation Platform to Treat Atrial Fibrillation
Shots:
- The US FDA has approved J&J medtech’s VARIPULSE PFA platform for treating drug refractory paroxysmal Atrial Fibrillation (AFib)
- Approval was based on the admIRE trial that showed of 291 patients, 100% attained acute procedural success, with 98% achieving first-pass isolation per vein and peak primary effectiveness was seen in 85% with 73-96 applications per vein. 12mos. data was published in Circulation
- The platform combines PFA therapy and advanced CARTO 3 mapping. It enables precise ablation with real-time catheter visualization, minimal to zero-fluoro workflows with ICE ultrasound. Its single-transseptal workflow supports efficient and predictable procedures for both routine and complex AFib cases
Ref: Johnson & Johnson | Image: Johnson & Johnson
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.