CardioFocus Piles Up Data On HeartLight Laser AF Ablation Catheter

Article preview from "The Gray Sheet" - May 20, 2013

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.

CardioFocus Piles Up Data On HeartLight Laser AF Ablation Catheter

Article preview from "The Gray Sheet" - May 20, 2013

CardioFocus Inc. is confident the growing set of data from experience with its HeartLight visually guided laser ablation balloon catheter will allow it to be competitive in the increasingly crowded U.S. atrial fibrillation (AF) ablation device market by 2015.

“The company has been very methodical in building a clinical story,” CardioFocus Executive Chairman Paul LaViolette told “The Gray Sheet.”

CardioFocus’ confidence in HeartLight is based on the results of several published clinical trials and more than 1,300 procedures in Europe since the device earned a CE mark in 2009, CardioFocus President and CEO Stephen Sagon said in an interview.

The company is especially encouraged by the results of the multicenter pulmonary vein remapping study, published in Heart Rhythm in January 2012. In the study, led by Srinivas R. Dukkipati of the Mount Sinai School of Medicine in New York, 52 patients treated for AF with HeartLight underwent a second procedure about three months later to determine the durability of the pulmonary vein isolation ablation.

The remapping results showed that 162 (86 percent) of the 189 pulmonary veins treated with HeartLight remained isolated an average of 105 days after the initial ablation procedure; and 32 of the 52 patients (62 percent) had all pulmonary veins still isolated. The trial also showed that the operators’ results generally improved as they gained more experience with HeartLight.

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