www.fdanews.com/articles/186713-cardiofocus-gains-approval-for-excalibur-balloon
CardioFocus Gains Approval for Excalibur Balloon
May 8, 2018
The FDA granted CardioFocus’ HeartLight Excalibur balloon approval for treating paroxysmal atrial fibrillation (PAF).
The device includes a feature that optimizes the magnitude and speed of target tissue contact during pulmonary vein isolation procedures.
It also incorporates technology that allows the user to make real-time adjustments to balloon size to facilitate optimal tissue contact.