AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel and conduit. The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount. The system is designed with a flexible shaft to facilitate access to difficult to reach coronary targets.
Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2434-2018