CardioFocus Piles Up Data On HeartLight Laser AF Ablation Catheter
This article was originally published in The Pink Sheet Daily
In addition to the more than 1,300 ablation procedures completed outside the U.S. with the unique visually guided ablation catheter, the venture-backed company is conducting an IDE trial in 21 U.S. centers, which it expects to complete in 2014.
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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.
Data on proton therapy, heart failure treatments, minimally invasive surgery and more.
With PMA approval Feb. 6, Johnson & Johnson/Biosense Webster's NaviStar ThermoCool and EZ Steer ThermoCool Navigational became the first cardiac ablation catheters approved by FDA specifically for treatment of atrial fibrillation