The following is a demonstration of the CSI Diamondback 360 orbital atherectomy
system for treating peripheral artery disease. The Diamondback 360 device
utilizes an eccentrically shaped crown. The crown is embedded with diamond chips
which gradually sand away plaque, including complex plaque morphologies
and calcified lesions. The Diamondback 360 device orbits using centrifugal
force to push the crown out against the lesion. Increasing centrifugal force
increases the orbit, this creates a smooth lumen approximately twice the
diameter of the crown. The device is designed to deflect from compliant
tissues. Multiple animal and human cadaver histological studies have shown
the design of the crown sands away the plaque without harming the native artery.
We will show the use of the Diamondback 360 for treating a lesion below the knee.
The location and severity of the lesion has been defined through angiography
prior to the procedure. The Diamondback 360 device is advanced through a small
introducer sheath, typically six french, which is placed in the femoral artery.
A viper wire is advanced through the introducer sheath and past the lesion.
The viper wire is the platform around which the Diamondback 360 orbits during
the procedure.
The flexible shaft is back loaded onto the Viper wire and tracks around
vascular bends to the treatment location. The Diamondback 360 is advanced until
the crown is positioned just proximal to the lesion. With the crown in this
position, ensure the guide wire is at least 10 centimeters past the distal end
of the lesion before activating the Diamondback 360.
Saline flows through a sheath covering the driveshaft. The low profile of the
shaft, combined with the orbiting eccentric crown, allows for continuous
blood flow during treatment. Testing has shown the combination of saline and
blood flow around the device reduces heat generation at the treatment site
which may reduce the risk of thermal trauma. The Diamondback 360 treatment is
initiated at a low orbital speed. Using the device handle the crown is advanced
through the lesion then retracted proximally, plaque is sanded in both
directions with each pass of the crown. With each successive pass the amount of
particulate diminishes as the lesion is sanded and reduced. The particulate
matter created is small enough to pass through the capillary bed of the distal
anatomy. Testing has shown that the average particle generated is 2.24
microns and 93.14 percent of particles generated were less than 8.2 microns, the
size of a red blood cell. In a recent clinical trial, no cases of capillary bed
overload with particulate were reported. If more plaque needs to be removed the
speed is increased to medium, this higher speed increases the crown orbit, pushing
the crown further into the lesion. As in the first treatment the Diamondback 360
will move through the lesion several times to continue debulking.
If needed, the orbital speed can be increased to the high setting. This will
produce the maximum orbit of the device and create a final lumen that is about
twice the size of the crown.
Use of the Diamondback 360 has produced a large, concentric, smooth lumen in the
diseased artery.
A final angiography is performed.
The Diamondback 360 and Viper wire are removed.