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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 Enrolls First Patient in CALCIUM 360° Clinical Trial 11/19/09
Study to Evaluate Clinical Benefits of Treating Peripheral Arterial Disease Behind and Below the Knee With Diamondback 360 ® PAD System Nov. 19, 2009- Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII), announces the first patient enrollment in its prospective, randomized CALCIUM 360° clinical trial, part of the company’s 360° Clinical Series. The CALCIUM 360° study will evaluate the treatment of peripheral arterial disease (PAD) behind and below the knee using CSI’s Diamondback 360 ® PAD System, a minimally invasive catheter for treating PAD anywhere in the leg. The first procedure was performed successfully by Dr. Nicolas Shammas at Trinity Medical Center , Bettendorf, Iowa . Dr. Shammas is the research director of the Midwest Cardiovascular Research Foundation in Iowa . He and Dr. Russell Lam , Presbyterian Hospital , Dallas , are the study’s co-principal investigators.  “Balloon angioplasty, the current standard of care for endovascular treatment, may cause severe dissection,...
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Cardiovascular Systems Initiates Voluntary Recall of ViperSheathTM Sheath Introducer 11/16/09
Company Distributes Product and Is Coordinating Recall with Manufacturer No Material Effect on CSI Financial Results Is Expected Nov. 16, 2009- Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) has announced a voluntary recall of all lots of the ViperSheath TM Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. CSI initiated the nationwide recall on November 2, 2009 . The ViperSheathTM Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI. It is a long-coil reinforced, kink-resistant catheter sheath that facilitates percutaneous, or through the skin, entry of an intravascular device. Thomas Medical initiated this recall due to the possibility of fractures in the device. In the event of a device fracture, separated segments of the device may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced,...
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