REDWOOD CITY, Calif., April 18, 2016 (GLOBE NEWSWIRE) -- Cardica, Inc. (Nasdaq:CRDC) today announced that the first U.S. cases using the company’s MicroCutter XCHANGE® 30 surgical stapler in thoracic surgery procedures have been performed by Robert J. Cerfolio, M.D., at the University of Alabama at Birmingham's Comprehensive Cancer Center. MicroCutter XCHANGE® 30, the world’s smallest-profile articulating stapler available, was successfully used during a number of recent robotically assisted cancer surgeries to remove portions of the lung, including both lobectomy and segmentectomy procedures.
Surgical staplers are routinely used in the U.S. in more than one million minimally invasive laparoscopic, video assisted or robotically assisted surgical procedures annually. The procedures performed by Dr. Cerfolio represent the first time the MicroCutter XCHANGE 30 has been used in thoracic surgeries under the expanded indication the company received from the U.S. Food and Drug Administration (FDA). In January, the FDA provided 510(k) clearance for use of the device with a white cartridge for the transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures. Previously, indications for use of the MicroCutter XCHANGE 30 included surgical procedures in the small and large intestine and the appendix.
“The MicroCutter XCHANGE 30 represents an important advancement in stapling that has the potential to change the landscape of thoracic surgery as we work to make it less invasive to our patients,” said Dr. Cerfolio. “With its small size and increased articulation, the MicroCutter XCHANGE 30’s unique design enables surgeons to maneuver around vessels more easily, potentially reducing dissection while achieving good hemostasis, all through a tiny five-millimeter port.”
“We are proud to support leading thoracic surgeons like Dr. Cerfolio as they constantly strive towards less-invasive approaches and better patient outcomes in thoracic surgery,” said Julian Nikolchev, president and CEO of Cardica. “We are pleased that, with this expanded FDA indication, the MicroCutter XCHANGE 30 is providing new options for surgeons, and enabling the continued progression toward these less-invasive approaches.”
About MicroCutter XCHANGE 30
The MicroCutter XCHANGE 30, the world’s first and only five-millimeter surgical stapler that articulates to 80 degrees, is a cartridge-based minimally invasive surgical stapling system. The device’s small size and wide articulation range is designed to enhance the surgeon’s access and visualization at the surgical site, and to mitigate limitations on the advancement of minimally invasive surgical approaches created by larger stapling devices. As the smallest-profile articulating stapler available today, the MicroCutter XCHANGE 30 is designed to reduce the amount of dissection and tissue handling required to position the stapler in confined spaces, enabling access to difficult to reach anatomy. In January 2016 the FDA provided 510(k) clearance for the use of the device for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as applications for transections, resection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and minimally invasive 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, that includes a cartridge-based articulating surgical stapling device with a five-millimeter shaft diameter and staples, is manufactured and cleared for use in the United States for transection and resection in multiple open or minimally invasive urologic, thoracic and pediatric surgical procedures, as well as application for transection, resection and/or creation of anastomoses in the small and large intestine and the transection of the appendix. The MicroCutter XCHANGE 30 White Cartridge staple has application in vascular tissue. 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 Cardica’s beliefs as to the benefits expected to be obtained from the use of the MicroCutter XCHANGE® 30, including that the MicroCutter XCHANGE 30 has the potential to change the landscape of thoracic surgery, has the potential to reduce dissection while achieving good hemostasis, and may reduce the amount of dissection and tissue handling required to position the stapler in confined spaces, enabling access to difficult to reach anatomy, are "forward-looking statements." There are a number of important factors that could cause results to differ materially from those indicated by these forward-looking statements, including: that Cardica may not be successful in its efforts to complete the development of its combination device (designed to use two different size cartridges) or achieve optimization of Cardica’s supply chain for its combination device; that Cardica may not receive regulatory approval for indications not currently approved; 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 December 31, 2015, under the caption “Risk Factors,” filed on February 10, 2016. 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.