REDWOOD CITY, Calif., Nov. 19, 2015 (GLOBE NEWSWIRE) -- Cardica, Inc. (Nasdaq:CRDC) today announced 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.
Importantly, 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.
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. Cardica's technology portfolio is intended to reduce operating time and facilitate minimally-invasive and robot-assisted surgeries. Cardica’s MicroCutter XCHANGE® 30 Stapler, a cartridge-based articulating surgical stapling device with a five-millimeter shaft diameter, is manufactured and cleared for use in the United States 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 Europe the device has applications in multiple general, gynecologic, urologic, thoracic and pediatric surgical procedures. In addition, Cardica manufactures and markets its automated anastomosis systems, the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System for coronary artery bypass graft (CABG) surgery, and has shipped over 56,500 units throughout the world.
The statements in this press release regarding expectations as to the potential of the MicroCutter device are "forward-looking statements." There are a number of important factors that could cause Cardica’s results to differ materially from those indicated by these forward-looking statements, including: that Cardica may not be successful in its efforts to make the improvements necessary to its enhanced MicroCutter device due to unanticipated technical or other difficulties; risks inherent in obtaining regulatory approvals; as well as other risks detailed from time to time in Cardica’s reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, under the caption “Risk Factors,” filed on November 12, 2015. Cardica expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. You are encouraged to read Cardica’s reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.
Contact: Bob Newell Vice President, Finance and Chief Financial Officer (650) 331-7133 firstname.lastname@example.org