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News Breaks
January 9, 2014
08:07 EDTCRDCCardica receives 510k clearance for MicroCutter XCHANGE
Cardica announced it obtained 510k clearance of the MicroCutter XCHANGE 30 device and blue staple cartridge for medium thickness tissue from the FDA for use in multiple open or minimally-invasive surgical procedures for the transection, resection and/or creation of anastomoses in small and large intestine, as well as the transection of the appendix.
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November 19, 2015
16:19 EDTCRDCCardica issues voluntary removal of MicroCutter XCHANGE 30 Blue Cartridge
Cardica nnounced that it has initiated a voluntary removal of the remaining inventory of approximately 225 MicroCutter XCHANGE 30 Blue Cartridges from the market. Currently, Cardica primarily sells the MicroCutter XCHANGE 30 Stapler in Europe which is labeled for use with the white cartridge only. Cardica has received two reports that using the blue cartridge with the MicroCutter XCHANGE 30 Stapler resulted in incomplete staple deployment. This can potentially result in an incomplete transection or anastomosis of tissue during the surgical procedure. There have been no reported clinical events or patient injury related to this issue with the Blue Cartridge. mportantly, the MicroCutter XCHANGE 30 Stapler with the white cartridge continues to be available for sale and use in Europe and the U.S. In Europe, the device is used in minimally invasive thoracic surgery also known as video-assisted thoracic surgery or VATS and in parenchymal surgery for organs including the liver, kidney and pancreas.
16:18 EDTCRDCCardica, Broadfin announce framework of settlement agreement
Cardica announced that they have reached an agreement in principle on a number of items and continue to negotiate in good faith in an effort to end the contested election of directors at Cardica's upcoming Annual Meeting of Stockholders to be held January 29, 2016. These items include: Reducing the size of the board from 8 members to 7; Agreed-upon Board slate will consist of Julian Nikolchev, Michael Kleine, Gregory Casciaro, Samuel Navarro and William Younger plus two additional nominees to be mutually agreed upon from a short list provided by the company to Broadfin; board slate will be finalized no later than November 27.

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