CSI Launches Diamondback Predator 360° PAD System

August 3, 2010—Cardiovascular Systems, Inc. (CSI) (St. Paul, MN) announced the launch of its second-generation Diamondback Predator 360° PAD system for treating peripheral arterial disease (PAD). The new generation of the device features improvements in the crowns and shaft for enhanced clinical performance and shorter procedure times. CSI received special 510(k) marketing clearance from the US Food and Drug Administration for the Diamondback Predator 360°, and the company has completed a limited market release with approximately 1,500 patients treated. The product is now available for broad commercialization.

According to the company, the Diamondback Predator 360° is a minimally invasive catheter system that offers interventionists a first-line therapy to quickly change lesion compliance, facilitate low-pressure balloon inflation if desired, and achieve a smooth vessel lumen without placing a stent. Both CSI PAD systems include a diamond-coated crown and an orbital mechanism of action to remove hardened plaque and restore blood flow in arteries throughout the leg, the company stated.

CSI has also initiated the CONFIRM PREDATOR registry, a prospective, multicenter study that will follow 500 PAD patients treated with the Diamondback Predator 360°. The registry will collect information on the device's performance, including overall plaque reduction, key acute safety measures, and techniques for optimal outcomes.

“CSI's PAD solutions are highly effective in removing plaque from arteries, and the Diamondback Predator 360° enhances the treatment process,” commented Prakash Makam, MD. “The ability to use lower speeds reduces the risk of complications during the procedure while removing a high percentage of plaque to achieve excellent acute outcomes in less time.”