Cardiovascular Systems, Inc. (CSII) recently received the U.S. Food and Drug Administration’s (FDA) conditional Investigational Device Exemption (IDE) approval. The approval is meant to evaluate the safety and effectiveness of the company’s Diamondback 360 degree System used to treat calcified coronary lesions.

Cardiovascular Systems is now authorized to begin its pivotal trial, ORBIT II, in early 2010 and initially enroll up to 100 patients at as many as 50 U.S. sites. The Diamondback 360 degree Orbital Atherectomy System is a minimally invasive catheter system used in the treatment of peripheral arterial disease (PAD).

It has been estimated that the peripheral arterial disease affects eight to twelve million people. It is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg), thus reducing blood flow.

Diamondback 360 degree System will be used to remove the calcified or fibrocalcific disease in patients so as to increase the effectiveness of other therapies. In 2008, Cardiovascular Systems had completed the first in-human ORBIT I coronary trial which was a success.

Cardiovascular Systems develops interventional systems for treating vascular diseases. Cardiovascular Systems was transformed into a public company through a merger with Replidyne, Inc. in early 2009. Cardiovascular had a fast-growing product portfolio but was short on liquidity. On the other hand, Replidyne had liquidity but no prospect for its product. Hence, the merger was a win-win transaction for both companies. Cardiovascular’s main competitors include Boston Scientific Corporation (BSX) and ev3, Inc. (EVVV).

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