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Earnings Calls In Brief

This article was originally published in The Gray Sheet

Executive Summary

Cardica readies revised PAS-Port 510(k): Firm plans to submit a 510(k) application for its PAS-Port proximal anastomic connector system by the end of 2007 for use during coronary artery bypass graft surgery, assuming success of an ongoing pivotal trial in the U.S. and Europe, Cardica reports during a July 31 earnings call. FDA's Circulatory System Devices Panel had recommended against clearance of an earlier PAS-Port 510(k) submission in April 2005 due to insufficient data (1"The Gray Sheet" May 2, 2005, p. 14). Cardica gained CE mark approval in July for European marketing of its C-Port xA distal anastomosis system, its next-generation C-Port; the firm is awaiting FDA clearance of a December 2005 510(k) submission for the device. The firm also will pursue U.S. and European clearance of its C-Port Flex A anastomosis system for use in open chest surgery in the second half of fiscal 2007, which began July 1. Cardica was denied a new technology Medicare "add-on" payment for its C-Port system in CMS' final inpatient rule...
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