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Corporate Profile

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease.

The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives.

The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital... More >>

Recent News

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Cardiovascular Systems Completes Coast Study Enrollment in Japan 12/01/14
International Coronary Trial Underway in United States and Japan Study to Assess the Safety and Efficacy of New Coronary Micro Crown Dec. 1, 2014- Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), announced that it has completed enrollment in Japan for its Coronary Orbital Atherectomy System Trial (COAST) study. Taking place in both Japan and the United States , the study is designed to assess the safety and efficacy, as well as economic outcomes, of CSI’s new investigational micro crown Orbital Atherectomy System (OAS) in treating severely calcified coronary lesions in patients suffering from Coronary Artery Disease (CAD). COAST requires a minimum of 50 patients in the U.S. at up to 15 sites and a minimum of 25 patients across 5 sites in Japan for a total of 100 patients to be enrolled. CSI surpassed its required number of enrollments in Japan with a total of 26 patients on November 20, 2014. Enrollment in the United States is expected to be completed in 2015. The 1.25 mm micro...
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Cardiovascular Systems Receives CE Mark for Stealth 360® Peripheral Orbital Atherectomy System 11/03/14
Download PDF Version Nov. 3, 2014- Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today announced that it has received CE (Conformité Européenne) Mark for its Stealth 360º Orbital Atherectomy System (OAS). Stealth 360º is a percutaneous OAS that is indicated to treat patients who suffer from peripheral arterial disease (PAD). “Securing CE Mark for Stealth 360º greatly expands our market opportunity and is an important milestone toward benefiting patients in Europe suffering from PAD—especially those with critical limb ischemia, (CLI) who have been underserved by other treatment options,” said David L. Martin , CSI president and chief executive officer. “A determining factor for CLI is calcium buildup in leg arteries, particularly small vessels below the knee. Our technology, with its unique mechanism of action, has demonstrated it can safely and effectively treat this complex disease, with lasting results.” PAD is a common circulatory disease in which plaque deposits build up on...
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