Preparation and Introduction
Before starting the procedure, the distal part of the handle is extended, sheathing the device. The device is then advanced over a guide wire until it reaches the aortic valve and the cutting assembly is positioned in the left ventricle.
The device is unsheathed by retracting the distal portion of the handle. The blades are now in the correct position for deployment.
To prepare the scoring of the valve, the blades are deployed to the appropriate diameter by rotating the deployment knob clockwise.
The safety lock is disengaged at the handle, the blades can be retracted across the aortic valve by pulling the trigger backwards. This scores the valve into three symmetrically separated areas, allowing ideal valve placement.
Contracting the Blades
The blades are contracted by rotating the deployment knob counter-clockwise. The device is now ready to be resheathed.
The Cutting Catheter is then resheathed by extending the distal end of the handle. Finally, the device is retrieved.
The Cutting Catheter for percutaneous aortic valve replacement preparation is an investigational device not available for sale at this time.