FDA grants CSI marketing clearance for Stealth 360° Orbital PAD System

Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII) has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), and has begun a limited market release for 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 proven orbital mechanism of action that protects healthy tissue while removing even the most difficult to treat plaque.

"The new Stealth 360° is as fast and easy to set up as a balloon or stent, but safer and more durable," said Dr. J. Mustapha, an interventional cardiologist at Metro Health Hospital in Grand Rapids, Mich., who treated the first patient with the Stealth 360°. "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."

Dr. Raymond Dattillo, an interventional cardiologist at St. Francis Medical Center, Topeka, Kan., added, "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."

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.

"With the Stealth 360°, physicians have a clinically proven, easy-to-use, front-line treatment for routine and complex cases," said David L. Martin, CSI president and chief executive officer. "Continued innovation, with our growing wealth of clinical data, will drive broad adoption and help physicians achieve a new and fantastic standard of care for the PAD patient."

CSI's limited market release will generate valuable feedback from physicians to establish best practices for device operation and provide a smooth transition to the new platform. Given the timing of FDA clearance and limited nature of the market release, significant revenue from the new product is not expected until CSI's fourth quarter, ending June 30, 2011.