Healthcare Industry News: dialysis
News Release - February 10, 2011
Cardiovascular Systems Files Special 510(k) for Stealth 360°(TM) Orbital Pad SystemNext-Generation Electric Powered Device Designed for Ease of Use, Shorter Procedures for Treating Peripheral Arterial Disease
ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII ), has filed a Special 510(k) application with the U.S. Food and Drug Administration (FDA). The application seeks marketing clearance for the Stealth 360°™ Orbital PAD System, a third-generation electric powered device for the treatment of peripheral arterial disease.
“Development of our Stealth 360° device and this 510(k) application are important milestones in CSI’s product development roadmap,” said David L. Martin, president and CEO of Cardiovascular Systems. “Greater ease of use and compelling data generated from nearly 2,500 patients in our ongoing clinical trials are key to establishing our unique technology for routine treatment of PAD patients on a large scale, including the more than 250,000 PAD patients who undergo surgery or amputations in the United States each year.”
Martin continued, “CSI has an ongoing commitment to listening to physicians’ feedback and responding with innovation. The Stealth 360° combines our Diamondback Predator 360° orbital mechanism of action and crown design with new features to greatly reduce system set-up times and put more control in the hands of physicians during procedures. We believe these innovations will encourage more physicians to adopt our technology to treat lesions from hip to toe, including the most difficult occlusions below the knee to restore outflow.”
The Stealth 360° system eliminates the large capital equipment portion of the current product for a more compact system. With simple, convenient speed adjustments on the handle, physicians can use lower speeds and have greater control during the procedure to achieve shorter spin times and a high percentage of plaque reduction.
CSI expects to begin a limited market release of the Stealth 360° during the third quarter of fiscal 2011, pending FDA marketing clearance.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing interventional treatment systems for vascular disease. The company’s Diamondback 360® and Diamondback Predator 360°™ 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 can lead to tissue loss and eventually 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. For more information visit the company’s Web site at www.csi360.com.
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 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. The Stealth 360° Orbital PAD System is currently under FDA review and is not available for distribution in the United States.
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 the release of the Stealth 360° to the marketplace during the third quarter of fiscal 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, FDA clearances and approvals, 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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