Cardiovascular Systems Inc (CSI), has filed a Special 510(k) application with the US Food and Drug Administration (FDA), seeking marketing clearance for the Stealth 360° Orbital PAD System, to treat peripheral arterial disease (PAD).
The Stealth 360° system is an electric powered device designed for ease of use, shorter procedures for treating PAD.
The Stealth 360° system eliminates the large capital equipment portion of the current product for a more compact system.
The system provides simple, convenient speed adjustments on the handle, with which physicians can use lower speeds and have greater control during the procedure to achieve shorter spin times and a high percentage of plaque reduction.
Cardiovascular Systems president and CEO David Martin said the Stealth 360° combines their 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," Martin said.