HeartLight Excalibur Balloon for Atrial Fibrillation Ablation Receives FDA Approval

CardioFocus, Inc. announced this week that their HeartLight Excalibur Balloon received US Food and Drug Administration (FDA) approval for the treatment of paroxysmal atrial fibrillation (AF).

The new tool builds upon the company’s previously FDA-approved HeartLight® Endoscopic Ablation System by adding features that improve the speed and magnitude of target tissue contact during pulmonary vein isolation procedures.

In 2015 the HeartLight® Endoscopic Ablation System was tested, and its visually guided laser balloon performed as successfully as traditional radiofrequency technology. The HeartLight system provided an easier alternative to the traditional ablation surgery and it’s steep learning curve.

The new Excalibur Balloon incorporates Dynamic Response™ technology, which places a remote in the physician’s hands and enables direct control of the balloon’s size in real-time. The balloon’s size flexibility allows for the accommodation of pulmonary veins of various sizes and shapes.

"We have seen encouraging results with the Excalibur Balloon," said Vivek Y. Reddy, MD, Director of Cardiac Electrophysiology and Helmsley Trust Professor of Medicine at The Icahn School of Medicine at Mount Sinai. “It obtains an impressive antral position and establishes even more tissue contact, which enables contiguous lesion sets.”

This compliant balloon design helps provide steady contact throughout an ablation procedure, including during the patient’s cardiac and respiratory cycles. Additionally, the balloon does not need to be fully deflated and re-inflated when rotated and repositioned in the blood vessel.

"This is a clear advance in the field of balloon-based AF ablation, delivering on the promise of an ultra-compliant balloon," said Reddy.

The Centers for Disease Control and Prevention estimate that 2.7—6.1 million people in the United States have atrial fibrillation, and that number will only rise as the population ages. Patients with atrial fibrillation have a stroke risk 4 to 5 times higher than people without the condition. Additionally, strokes caused by complications from AF tend to be more severe than strokes from other causes.

"The FDA approval of the Excalibur Balloon is a significant milestone for CardioFocus, as it is the first ultra-compliant balloon introduced into the US market for AF ablation," said Burke T. Barrett, Chief Operating Officer of CardioFocus. "The Excalibur Balloon capitalizes on the existing features of our HeartLight System, which offer an accurate, consistent, and controlled treatment option for PAF patients whose atrial arrhythmias are insufficiently controlled with medication."

The technology is currently available in 20 European countries following CE Mark approval in September 2017 and is approved for use in Japan.

CardioFocus expects to launch the HeartLight Excalibur Balloon commercially in the United States in the third quarter of 2018.

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