Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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...

You may also be interested in...



Cardica Says PAS-Port Proximal Anastomosis System Is A Breakthrough

Cardica boasts it has achieved a major breakthrough in cardiac bypass surgery with its PAS-Port and C-Port fully automated anastomosis system

Cardica Says PAS-Port Proximal Anastomosis System Is A Breakthrough

Cardica boasts it has achieved a major breakthrough in cardiac bypass surgery with its PAS-Port and C-Port fully automated anastomosis system

Cardica Claims Breakthrough In Endoscopic Heart Surgery

Widespread adoption of minimally invasive heart surgery as an alternative to both open surgery and percutaneous intervention could be just around the corner

Related Content

UsernamePublicRestriction

Register

MT023844

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel