Cardica Receives 510(k) Clearance For Both MicroCutter XCHANGE™ 30 White Cartridge And New Material
REDWOOD CITY, Calif., Feb. 27, 2014 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced it received 510(k) clearance from the U.S. Food and Drug Administration (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 510(k) 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 510(k) 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.
"My patients will benefit from the significant advances in stapling technology offered by the 5mm XCHANGE 30," said Mark Wulkan, M.D., professor of surgery and chief of the division of pediatric surgery at Emory University School of Medicine and surgeon-in-chief of Children's Healthcare of Atlanta. "The small size sets the XCHANGE 30 apart from other surgical stapling technologies available, meeting the need for less invasive surgical tools for my patients. I see a particular need for this technology in bowel resections in small patients."
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, a cartridge-based articulating surgical stapling device with a five-millimeter shaft diameter, is manufactured and cleared for use in a variety of gastrointestinal procedures and appendectomies in the United States, and is marketed for a wide range of surgical procedures in Europe. Cardica is developing the Cardica® MicroCutter XCHANGE™ 45, a cartridge-based microcutter device with an eight-millimeter shaft to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter XCHANGE 45 product requires 510(k) review and CE Mark and is not yet commercially available in the U.S. or internationally. 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 49,000 units throughout the world.
The statements in this press release regarding the benefits expected for patients from Cardica's MicroCutter XCHANGE 30 and cartridges are "forward-looking statements." There are a number of important factors that could cause Cardica's results to differ materially from those indicated by this forward-looking statement, including: that Cardica may not be successful in its efforts to commercialize the XCHANGE 30 due to unanticipated technical or other difficulties; that prospective customers in the United States may not perceive the benefits of the XCHANGE 30 to be sufficient to warrant its purchase; that prospective customers in the United States may be constrained by pricing pressures or purchasing requirements in the hospitals and facilities in which they work, which could prevent them from purchasing the XCHANGE 30; 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, 2013, under the caption "Risk Factors," filed on February 5, 2014. 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.
SOURCE Cardica, Inc.