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News Breaks | | | | March 15, 2013 | | 08:00 EDT |  | CSII | Cardiovascular Systems completes PMA submission of orbital atherectomy system
Cardiovascular Systems announced that it has submitted its Premarket Approval, or PMA, application to the U.S. Food and Drug Administration for its orbital atherectomy system, used to treat calcified coronary arteries. The completed PMA application marks another major coronary milestone for CSI, following the release of ORBIT II pivotal trial results at the recent 2013 American College of Cardiology conference. CSI’s technology produced clinical outcomes that exceeded the trial’s two primary safety and efficacy endpoints by a significant margin. | |
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News For CSII From The Last 14 Days Check below for free stories on CSII the last two weeks. |
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