Cardiovascular Receives Coronary FDA Marketing Approval - Quick Facts

(RTTNews) - Cardiovascular Systems Inc. (CSII) Tuesday said it has received PMA approval from the U.S. Food and Drug Administration to market its Diamondback 360 Coronary Orbital Atherectomy System or OAS as a treatment for severely calcified coronary arteries.

David Martin, CEO, said, "FDA approval of our Diamondback 360 Coronary OAS allows us to bring to market the first new coronary atherectomy system in more than two decades."

This approval opens up a large, underserved U.S. market opportunity for the company, estimated to exceed $1.5 billion annually.

The company will provide more details on FDA approval and its launch plans for the Diamondback 360 Coronary OAS during its upcoming fiscal 2014 first-quarter results conference call.