The CardioFocus Catheter System consists of the following items:

Balloon Catheter
A disposable multi-lumen catheter equipped with an inflatable balloon at its distal end is specially shaped to reside in the pulmonary vein orifice. The balloon comes in three sizes, 20, 25 and 30 mm. An Arc Generator laser delivery fiber, included with the catheter, provides the conduit through which to deliver the laser energy. The Arc Generator is advanced through the central lumen of the Balloon Catheter and can be moved and rotated, independent of the balloon position, to adjust the location of energy delivery. Separate lumens are available for balloon inflation/deflation and endoscope access.

CardioFocus Balloon Catheter in the Deflectable Sheath

Deflectable Sheath Introducer The disposable Deflectable Sheath Introducer is inserted in the femoral vein and advanced to 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.

Endoscope
The 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 the balloon. 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 20 procedures.

Laser Source & Cooling Console Laser energy for the system is delivered through a 58-watt continuous wave, 980nm diode laser system. During use of the catheter, the Balloon Cooling Console provides the energy to circulate sterile fluid through the catheter's balloon as well as the pumping force necessary to inflate and deflate the balloon on command.

Endoscope Illumination and Display
There are commercially available endoscope illumination sources and displays that provide for a video display of the endoscope image.