Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), has filed a Special 510(k) application with the U.S. Food and Drug Administration (FDA). The application seeks marketing clearance for the Stealth 360°™ Orbital PAD System, a third-generation electric powered device for the treatment of peripheral arterial disease.
“Development of our Stealth 360° device and this 510(k) application are important milestones in CSI’s product development roadmap,” said David L. Martin, president and CEO of Cardiovascular Systems. “Greater ease of use and compelling data generated from nearly 2,500 patients in our ongoing clinical trials are key to establishing our unique technology for routine treatment of PAD patients on a large scale, including the more than 250,000 PAD patients who undergo surgery or amputations in the United States each year.”
Martin continued, “CSI has an ongoing commitment to listening to physicians’ feedback and responding with innovation. The Stealth 360° combines our Diamondback Predator 360° orbital mechanism of action and crown design with new features to greatly reduce system set-up times and put more control in the hands of physicians during procedures. We believe these innovations will encourage more physicians to adopt our technology to treat lesions from hip to toe, including the most difficult occlusions below the knee to restore outflow.”
The Stealth 360° system eliminates the large capital equipment portion of the current product for a more compact system. With simple, convenient speed adjustments on the handle, physicians can use lower speeds and have greater control during the procedure to achieve shorter spin times and a high percentage of plaque reduction.
CSI expects to begin a limited market release of the Stealth 360° during the third quarter of fiscal 2011, pending FDA marketing clearance.
Source: Cardiovascular Systems, Inc.