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Replidyne and Cardiovascular Systems Sign Merger Agreement
Date:11/4/2008

ional treatment systems for vascular disease. CSI's initial product, the Diamondback 360 degrees Orbital Atherectomy System, is a minimally invasive catheter system for the treatment of peripheral arterial disease, or PAD. PAD affects approximately 8 to 12 million people in the U.S. PAD is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg), reducing blood flow. The plaque deposits range from soft to calcified, with calcified plaque being difficult to treat with traditional interventional procedures. The Diamondback 360 degrees is capable of treating a broad range of plaque types both above and below the knee, including calcified vessel lesions, and addresses many of the limitations associated with existing treatment alternatives.

The Diamondback 360 degrees utilizes the orbital rotation of a diamond grit coated offset crown that is attached to a flexible drive shaft. Physicians position the crown at the site of an arterial plaque lesion and remove the plaque by causing the crown to orbit against it, creating a smooth lumen, or channel, in the vessel. The Diamondback 360 degrees is designed to differentiate between plaque and compliant arterial tissue, a concept known as "differential sanding." The particles of plaque resulting from differential sanding are generally smaller than red blood cells and are carried away by the blood stream. As the physician increases the rotational speed of the drive shaft, the crown rotates faster and centrifugal force causes the crown to orbit, creating a lumen with a diameter that is approximately twice the diameter of the device. By giving physicians the ability to create different lumen diameters by changing rotational speed, the Diamondback 360 degrees can reduce the need to use multiple catheters of different sizes to treat a single lesion.

In August 2007, the U.S. FDA granted 510(k) clearance for the use of the Diamondback 360 as a therapy in patients with PAD. The Company comme
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SOURCE Replidyne, Inc.
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