FDA Clears CSI's Stealth 360° Orbital PAD System

March 17, 2011—Cardiovascular Systems, Inc. (CSI, St. Paul, MN) announced that it has received 510(k) marketing clearance from the US Food and Drug Administration for the Stealth 360° orbital peripheral arterial disease (PAD) system. CSI has begun a limited market release to generate feedback from physicians to establish best practices for device operation and to provide a smooth transition to the new platform.

According to CSI, the Stealth 360° utilizes CSI's Diamondback Predator 360° orbital mechanism of action with optimal shaft and crown configurations to protect healthy tissue while removing difficult-to-treat plaque and incorporates a simpler design to provide physicians with complete control of the device.

“The new Stealth 360° is as fast and easy to set up as a balloon or stent but is safer and more durable,” commented Jihad Mustapha, MD. “This device provides effective treatment for the entire leg, including small calcified vessels below the knee that are critical to achieving blood flow to the foot.”

Raymond Dattilo, MD, commented, “The Stealth 360° puts the controls at my fingertips, giving me better tactile feel and allowing me to operate the device independently. The easier setup, along with the demonstrated safety and effectiveness of CSI's orbital devices positions this as an essential tool for treatment of PAD.”