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CardioFocus Files Pre-Market Approval App for HeartLight Device

The Food and Drug Administration has accepted and is to review the pre-market approval application for the HeartLight device from CardioFocus.

About the HeartLight Device

The HeartLight device is a visually-guided, minimally invasive cardiac ablation device used to correct Atrial Fibrillation.

Atrial fibrillation is a heart arrhythmia that causes a fast and irregular heartbeat. Sometimes it comes and goes, but it can also develop into a regular problem that calls for treatment. Although atrial fibrillation isn’t life-threatening itself, it can lead to heart attacks and/or strokes. One treatment option is cardiac ablation.

An ablation device is a device used to scar and/or destroy the tissue of the heart that is causing the arrhythmia. The HeartLight device does this in a minimally invasive manner.

The Heartlight works by inserting a catheter into the leg of the patient, threading it up through the veins to the patient’s heart, and expanding a balloon inside the affected chambers of the heart. The balloon temporarily push out the blood and gives surgeons a clear view of the inside of the heart. Doctors then use a laser to burn away the tissue that causes the arrhythmia.

About the Pre-Market Approval Application

According to MassDevice, the application is supported by data from a 353-patient study. Patients in the study all suffered from atrial fibrillation and were randomly assigned either treatment from the HeartLight device, or the current standard procedure, radiofrequency ablation.

The results of the study showed similar safety and effectiveness for both methods of treatment, however, the newer HeartLight treatment did have much higher procedure times.

Dr. Vivek Reddy, from Mt. Sinai Hospital in New York, presented the data in May’s Heart Rhythm Society meeting held in Boston. He addressed the procedural time issue, saying:

“I was pleased. On 1 hand, I’d love to see the laser work better than point-by-point ablation; on the other hand, the majority of these operators have never touched this device and were expected to perform as well as a technology they’ve used hundreds of times. One important point is you have to remember the physicians that performed the RF ablation procedures had a lot of experience with RF ablation. Each of them had performed hundreds, if not thousands, of RF ablations. In contrast, the physicians in the study had relatively little experience using the laser balloon. Even at the conclusion of the study they had relatively little experience – none of the operators had performed more than 15 procedures. Despite that, again, there was similar efficacy. Why does that matter? If we look at European experience where this device has been approved, just as with the cryoballoon, you have improvements in efficacy, you have improvements in safety.”

There has been another update concerning the procedural time issue. Expanded results of the study show that with experience, operators have cut down on procedure times significantly.

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