Cardiovascular Systems (CSI) has received the US Food and Drug Administration (FDA) 510(k) marketing clearance and has begun a limited market release of the Stealth 360° Orbital PAD System.
The Stealth 360° propels CSI into the forefront of treating peripheral arterial disease (PAD) with a simpler design that gives physicians complete control of device operation.
Additionally, the new system utilizes CSI’s orbital mechanism of action that protects healthy tissue while removing even the most difficult to treat plaque.
The Stealth 360°’s advanced, electric-powered handle features a power on/off button and speed selection controls conveniently positioned for ease of use and greater physician control.
By eliminating the compressed air tank and separate speed controller of previous CSI systems, the Stealth 360° reduces device set-up and lab staff time.
The Stealth 360° incorporates the Diamondback Predator 360° orbital mechanism of action, optimal shaft and crown configurations.
The shaft is flexible and suited for compromised run-off, vessel bends or tortuous anatomy.