Healthcare Industry News:  Stealth 360 

Devices Interventional FDA

 News Release - March 17, 2011

Cardiovascular Systems Receives FDA 510(k) Marketing Clearance for Stealth 360°(TM) Orbital PAD System

Easy-to-Use Device Minimizes Procedure Time

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII ) has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), and has begun a limited market release for the Stealth 360°™ Orbital PAD System. The Stealth 360° propels CSI into the forefront of treating peripheral arterial disease (PAD) with a simpler design that gives physicians complete control of device operation. Additionally, the new system utilizes CSI’s proven orbital mechanism of action that protects healthy tissue while removing even the most difficult to treat plaque.

“The new Stealth 360° is as fast and easy to set up as a balloon or stent, but safer and more durable,” said Dr. J. Mustapha, an interventional cardiologist at Metro Health Hospital in Grand Rapids, Mich., who treated the first patient with the Stealth 360°. “This device provides effective treatment for the entire leg, including small calcified vessels below the knee that are critical to achieving blood flow to the foot.”

Dr. Raymond Dattillo, an interventional cardiologist at St. Francis Medical Center, Topeka, Kan., added, “The Stealth 360° puts the controls at my fingertips, giving me better tactile feel and allowing me to operate the device independently. The easier setup, along with the demonstrated safety and effectiveness of CSI’s orbital devices, positions this as an essential tool for treatment of PAD.”

The Stealth 360°’s advanced, electric-powered handle features a power on/off button and speed selection controls conveniently positioned for ease of use and greater physician control. By eliminating the compressed air tank and separate speed controller of previous CSI systems, the Stealth 360° significantly reduces device set-up and lab staff time.

The Stealth 360° incorporates the Diamondback Predator 360° orbital mechanism of action, optimal shaft and crown configurations. Preliminary results in nearly 800 lesions from CSI’s Confirm II Predator study demonstrate that the crown is designed for maximal plaque removal at lower speeds in the shortest amount of time. The shaft is flexible and suited for compromised run-off, vessel bends or tortuous anatomy.

“With the Stealth 360°, physicians have a clinically proven, easy-to-use, front-line treatment for routine and complex cases,” said David L. Martin, CSI president and chief executive officer. “Continued innovation, with our growing wealth of clinical data, will drive broad adoption and help physicians achieve a new and fantastic standard of care for the PAD patient.”

CSI’s limited market release will generate valuable feedback from physicians to establish best practices for device operation and provide a smooth transition to the new platform. Given the timing of FDA clearance and limited nature of the market release, significant revenue from the new product is not expected until CSI’s fourth quarter, ending June 30, 2011.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular disease. The company’s Diamondback 360®, Diamondback Predator 360°™ and Stealth 360° Orbital PAD Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. As many as 12 million Americans suffer from peripheral arterial disease (PAD), which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) reducing blood flow. Symptoms include leg pain when walking or at rest, and tissue loss that can lead to limb amputation. In August 2007, the U.S. FDA granted 510(k) clearance for the use of the Diamondback 360° as a therapy for PAD, and CSI commenced a U.S. product launch in September 2007. Since then, over 37,000 procedures have been performed using the Diamondback 360° in leading institutions across the United States. CSI also has commenced its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its Diamondback 360° System in treating coronary arteries.

For more information visit the company’s Web site at

Product Disclosure

The Diamondback 360®, Diamondback Predator 360® and Stealth 360°™ Orbital PAD Systems 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 systems are 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.

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 provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding our expectation that the innovations of the Stealth 360°, with our growing wealth of clinical data, will drive broad adoption of our technology by physicians and make it an integral part of their approach to treating PAD; the effect of our limited market release of the Stealth 360°; and our expectation that significant revenue from the new product is not expected until our fourth quarter, ending June 30, 2011, 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, physician acceptance of the Stealth 360°, the impact of competitive products and pricing, the effectiveness of the Stealth 360°, and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. 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.

Source: Cardiovascular Systems

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