Healthcare Industry News:  dialysis 

Devices Interventional

 News Release - August 3, 2010

Cardiovascular Systems Launches Diamondback Predator 360° PAD System

Enhanced, Minimally Invasive Device Expands Peripheral Arterial Disease Treatment Options

ST. PAUL, Minn.--(HSMN NewsFeed)--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 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.”

Safe Harbor

Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are intended to enjoy the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding the CONFIRM PREDATOR registry are forward-looking statements. These statements involve risks and uncertainties which could cause results to differ materially from those projected, including but not limited to the potential for unanticipated delays in enrolling medical centers and patients for studies; new data or events that may disrupt plans for these studies; unexpected results or clinical outcomes in our trials, and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.

About Cardiovascular Systems, Inc.

Cardiovascular Systems Inc., (CSI) (Nasdaq: CSII ) based in St. Paul, Minn., is a medical device company focused on providing clinically proven, safe and effective interventional solutions for vascular disease. The company’s Diamondback 360® PAD System removes calcified and fibrotic plaque in small and large peripheral vessels, and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. In August 2007, the U.S. FDA granted 510(k) clearance for the use of the Diamondback 360° as a therapy for PAD (peripheral arterial disease), and CSI commenced a U.S. product launch in September 2007. Since then, more than 25,000 procedures have been performed using the system. In July 2010, the company launched the Diamondback Predator 360° PAD System, its second-generation product with upgrades to crowns and the shaft, providing physicians greater ease of use and shorter procedure times. For more information visit the company’s website at www.csi360.com.

Product Disclosure

The Diamondback 360® PAD System and Diamondback Predator 360°™ PAD System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The system is contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.


Source: Cardiovascular Systems

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