CardioFocus lands CE Mark for next-gen atrial fibrillation balloon

CardioFocus said today that it won CE Mark approval for its HeartLight Excalibur balloon, designed for the treatment of atrial fibrillation.

The Marlborough, Mass.-based company’s device combines the HeartLight endoscopic ablation system with features that optimize the speed and magnitude of target tissue contact during pulmonary vein isolation procedures, according to CardioFocus.

The Excalibur balloon uses CardioFocus’ Dynamic Response technology, which is used to maximize the balloon’s engagement with a person’s pulmonary viens, while cutting the time needed to complete ablation procedures.

“The new HeartLight Excalibur Balloon is designed to capitalize on the existing features of our HeartLight System, which offer an accurate, consistent and controlled treatment option for AF patients whose heart arrhythmias are insufficiently controlled with medication. Excalibur will make the procedure even easier to perform,” COO Burke Barrett said in prepared remarks. “The timely clinical evaluation and subsequent approval of Excalibur in Europe reflects the strong performance of the technology and highlights the significant advances made with the Excalibur Balloon.”

“We are delighted by the results we experienced during our clinical evaluation of the HeartLight Excalibur Balloon,” Petr Neužil, from the Na Homolce Hospital in Prague, Czech Republic, added.

“We consistently noted that the Excalibur Balloon is easier and faster to use, establishes significantly more contact with the vein and can consistently obtain an impressive antral position. I believe that this next-generation balloon will receive an enthusiastic reception by my physician colleagues.”

The company said it expects to begin a controlled launch of the Excalibur device in Europe in the fourth quarter of this year.

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