Safety Concerns Sink Medtronic A-Fib Catheter Ablation System At Panel
This article was originally published in The Gray Sheet
Executive SummaryRisks associated with Medtronic’s Phased RF catheter ablation system for atrial fibrillation outweigh the benefits of the device, FDA’s Circulatory System Devices panel concluded in an 8-2 vote on Oct. 27.
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The European registry is the first observational “real world” study of Medtronic’s PVAC Gold multi-electrode ablation catheter.
Device therapies for atrial fibrillation (AF) have so far failed to result in compelling efficacy across all types of disease and patients. The rates of elimination of AF following a catheter ablation procedure range from 30% to 80% according to the type of patient and the definition of success. The question of why success rates aren’t yet sufficient after a great deal of investment is an area of active pursuit, and one that opens up the door for next-generation AF device companies seeking to improve upon the results achieved to date.