FDA Approves Cardiovascular CSI’s Stealth 360 System for Treatment of Peripheral Arterial Disease

St. Paul, MN-based Cardiovascular Systems, Inc. (CSI) has just received FDA 510(k) approval for its new Stealth 360° Orbital PAD System. The Stealth 360° is a catheter based system which uses an orbital technology similar to that of CSI’s Diamondback 360° which we covered a few years ago. The system treats peripheral arterial disease (PAD) by sanding away plaque buildup without damaging the soft arterial tissue. Breaking up the plaque in this manner allows the surgeon to use lower pressure when inflating a balloon to finish the procedure, thereby reducing risk of damaging the artery.
From the announcement:

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° significantly 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. Preliminary results in nearly 800 lesions from CSI’s Confirm II Predator study demonstrate that the crown is designed for maximal plaque removal at lower speeds in the shortest amount of time. The shaft is flexible and suited for compromised run-off, vessel bends or tortuous anatomy.