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Cardica gains CE mark for improved anastomosis system:

This article was originally published in Clinica

Executive Summary

Cardica has CE marked its C-Port Flex A Anastomosis System, a device designed to facilitate minimally-invasive coronary artery bypass graft (CABG) surgery, for sale in Europe. The product is a variation on a previously approved Cardica product, the C-Port xA Distal Anastomosis System. Its advantages over the earlier version include a flexible shaft intended to better allow surgeons to join blood vessels in hard-to-reach areas of the heart. The Redwood City, California, company claims that it can create anastomoses in vessels as small as one millimetre in internal diameter, and can be used in either on- or off-pump CABG procedures. The Flex A received 510(k) clearance from the US FDA in March 2007 (see Clinica No 1253, p 24).

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