This article was originally published in The Gray Sheet
Executive SummarySubmits a premarket approval application on June 8 to FDA for peripheral vascular applications of its CVX-300 excimer laser system, Robert DePasqua, company president and CEO announced at the June 15-17 Piper Jaffray Conference in Minneapolis. The firm has been marketing the system for treatment of coronary artery disease since it received agency approval in February ("The Gray Sheet" March 1, p. 9). The firm also expects summer approval of a PMA supplement for its second generation laser system, and a PMA supplement for a third-generation system, the Vitess rapid- exchange laser catheter, will be submitted to FDA in the fall.
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