Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), has launched its second-generation product, the Diamondback Predator 360°™ PAD System, for the treatment of peripheral arterial disease (PAD). The new device uses the same mechanism of action as the clinically proven Diamondback 360® PAD System with improvements in the crowns and shaft for enhanced clinical performance and shorter procedure times. CSI received Food and Drug Administration special 510(k) marketing clearance for the Diamondback Predator 360°, and the company has completed an extensive limited market release with approximately 1,500 patients treated. The product is now available for broad commercialization.
“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.”
The Diamondback Predator 360°, a minimally invasive catheter system, offers physicians 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. With the Diamondback Predator 360°, physicians can now treat PAD more efficiently, achieving shorter procedure times and greater plaque reduction to address complex lesions located anywhere between the hip and toes. Both CSI PAD systems include a diamond-coated crown and unique orbital mechanism of action to remove hardened plaque to restore blood flow in arteries throughout the leg. The core technology of these systems is designed to avoid damage to blood vessels to possibly delay restenosis and foster better long-term patient outcomes.
"Cardiovascular Systems' PAD solutions are highly effective in removing plaque from arteries, and the Diamondback Predator 360° enhances the treatment process," said Dr. Prakash Makam, medical director of clinical research at Community Hospital in Munster, Ind. "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."
CSI has also initiated the CONFIRM PREDATOR registry, a prospective, multi-center study which will follow 500 PAD patients treated with the Diamondback Predator 360°. The new registry will collect information on Diamondback Predator 360° performance, including: overall plaque reduction, key acute safety measures and techniques for optimal outcomes.
"The introduction of the Diamondback Predator 360° underscores our commitment to listen to physicians' feedback and respond with superior tools to treat PAD," said David L. Martin, president and chief executive officer of Cardiovascular Systems. "We are dedicated to evidence-based medicine, and our prospective studies, well over 1,000 patients strong, are informing decisions made by patients and their families, physicians and payers. Physicians who have used the Diamondback Predator 360° have found the enhanced system gives them reliable, safe performance and favorable outcomes."
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