The CardioFocus Endoscopic Ablation System
The CardioFocus Endoscopic Ablation System consists of the following items
A disposable, 12F, multi-lumen catheter has an inflatable balloon at its distal end made of a compliant material and specially shaped to provide wide areas of contact surrounding the pulmonary vein ostium. The balloon size is dynamic as a function of the pressure used to provide inflation; as a result it can span from under 20 mm to over 30 mm in diameter making a single catheter able to span a wide range of vein sizes. An Arc Generator laser delivery fiber, included with the catheter, provides the conduit to deliver a 30-degree arc of laser energy. The Arc Generator is advanced through the central lumen of the Balloon Catheter and can be moved and rotated to adjust the location of energy delivery. The fluid within the balloon is used to cool the arc generator and passes through the central lumen of the catheter as it re-circulates through the compliant balloon. Separate lumens are available for balloon inflation/deflation, endoscope access and illumination.
Deflectable Sheath Introducer
The disposable 12F ID Deflectable Sheath Introducer is inserted in the femoral vein and advanced into the left atrium via a transseptal puncture. It is deflectable through more than 180 degrees and provides easy access to each of the four pulmonary veins to facilitate placement of the Balloon Catheter.
EndoscopeThe reusable Endoscope is a 500-micron diameter device with an extremely wide field of view. It is inserted into the Balloon Catheter at the beginning of the procedure and advanced until its tip is located at the proximal end of the balloon. It provides the physician with a unique view of the entire front, side and part of the back of whatever the balloon contacts. The operator can observe where the balloon makes contact with the tissue and can monitor and adjust the actual location of the delivery of the projected energy. The Endoscope lumen is not in contact with patient body fluids and, as a result, the Endoscope is reusable for approximately 5-10 procedures.
Integrated EAS Console
All functions necessary to perform ablation procedures with the Endoscopic Ablation System are contained within a single compact console. Compliant balloon adjustment, endoscopic image management using the Light Track software, the selection of energy delivery parameters and the issuance of a final procedure report are easily activated from the touch screen.