The FDA has granted 510(k) marketing clearance to Cardiovascular Systems for its Stealth 360° Orbital PAD System, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae.
The St. Paul, Minn.-based company has begun a limited release of the product, which utilizes an orbital mechanism of action for removing plaque. The Stealth 360° features a power on/off button and speed selection controls, and there is no compressed air tank.
The device incorporates the Diamondback Predator 360° orbital mechanism of action, optimal shaft and crown configurations. Preliminary results in nearly 800 lesions from the Confirm II Predator study demonstrated that the crown is designed for maximal plaque removal. The shaft is suited for compromised run-off, vessel bends or tortuous anatomy, the company said.
Cardiovascular Systems said its limited market release will generate feedback from physicians to help establish best practices for device operation and provide a transition to the new platform. The company also said that due to the limited nature of the market release, significant revenue from the new product is not expected until the fourth quarter, ending June 30.