CardioFocus Piles Up Data On HeartLight Laser AF Ablation Catheter
This article was originally published in The Gray Sheet
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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Enrollment in CardioFocus’ U.S. pivotal trial of the HeartLight endoscopic atrial fibrillation ablation system is complete. A small study shows that small wires implanted in the head may cure chronic headaches. Biolase and Auris announce plans to build a cataract removal robot.
Novel arrhythmia mapping technologies, once they are clinically proven and validated, could change practice paradigms in the atrial fibrillation ablation space but in the meantime work continues on nearer-term advances that could make AF ablation more effective and durable. Three of the most promising – contact force sensing, endoscopic laser ablation, and atrial fibrosis imaging, from such companies as Endosense, Biosense Webster, CardioFocus, and Marrek – have recently achieved some important milestones in their journeys toward US market approval.
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.