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News Breaks
February 27, 2014
08:07 EDTCRDCCardica receives 510k clearance for MicroCutter XCHANGE
Cardica announced it received 510k clearance from the FDA for its MicroCutter XCHANGE 30 white cartridge for the stapling of thin tissue 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. In addition, Cardica obtained 510k clearance for an additional plastic material contained within the MicroCutter XCHANGE 30 blue cartridge for use in medium thickness tissue. This material was submitted as a Special Premarket Notification 510k for the MicroCutter XCHANGE 30 device, which received FDA clearance in January 2014. With these clearances received Cardica does not have any other submissions pending at the FDA.
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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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