FDA approves HeartLight Excalibur Balloon for the treatment of paroxysmal atrial fibrillation.- CardioFocus Inc.

CardioFocus, Inc. has announced that the FDA has granted approval for the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of paroxysmal atrial fibrillation (PAF) . The Excalibur Balloon leverages the proven universal balloon design of the company's FDA-approved HeartLight Endoscopic Ablation System and introduces an advanced feature set that optimizes the speed and magnitude of target tissue contact during pulmonary vein isolation (PVI) procedures.

In addition to its ultra-compliant design that enables adaptive vein conformance, the Excalibur Balloon also incorporates proprietary Dynamic Response technology. This feature allows the user to make real-time adjustments to balloon size, allowing for optimal tissue contact. These combined features are designed to maximize the engagement of the balloon with the pulmonary veins, while decreasing the time required to complete ablation procedures. The technology has CE Mark and is now offered at 20 European centers. The company expects to begin a full commercial launch of the Excalibur Balloon in the U.S. in the third quarter of 2018.

Comment:The HeartLight technology is used during pulmonary vein isolation procedures, using the balloon to isolate the target area and providing the physician with a direct view of the tissue being worked on. A laser is used to ablate cardiac tissue without having to rely on X-rays or EP cardiac mapping to find and kill the target.