Cardica Submits MicroCutter XCHANGE™ 30 510(k) Application For Marketing Clearance
REDWOOD CITY, Calif., Aug. 16, 2013 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that it filed regulatory documents with the U.S. Food and Drug Administration (FDA) for marketing clearance of the MicroCutter XCHANGE™ 30, a cutting and stapling device designed to be used in multiple open and minimally invasive surgical procedures. The XCHANGE 30 has a cross-sectional area six times smaller than conventional surgical staplers and articulates up to 80 degrees in each direction. The lower profile provides greater access through a 5 mm trocar.
The submission to the FDA includes the results of Cardica's recently completed MicroCutter European Trial (MET1). In the MET1 study, the MicroCutter XCHANGE 30 met the primary endpoint, freedom of MicroCutter-related severe adverse events when compared to historical controls from the medical literature, with only one event in 160 patients enrolled and 423 deployments.
"The filing of our 510(k) application represents the culmination of effort from many key contributors including the employees who worked tirelessly to deliver an innovative device that addresses a surgical need, the leading physicians who tested the XCHANGE 30 and provided invaluable feedback and the patients that underwent surgical procedures facilitated by the device," commented Bernard A. Hausen, M.D., Ph.D., President and Chief Executive Officer of Cardica. "Pending market clearance by the FDA, we look forward to introducing the MicroCutter XCHANGE 30 in the United States, the world's largest surgical stapling market."
About the MicroCutter XCHANGE 30
Cardica's MicroCutter XCHANGE 30 is available in select centers in Europe today. The device has a cross-sectional area six times smaller than conventional staplers, and articulates up to 80 degrees. The device uses reloadable cartridges with a 30-millimeter staple line length. Laparoscopic procedures today are primarily performed through 5- to 10-mm trocars ports. To accommodate conventional stapling technology, however, surgeons are forced to use 12- or 15-mm trocars, which can result in high post-operative pain, port site infection or ventral hernias. These complications can prolong surgical time, delay discharge, and result in unnecessary hospital readmissions. The smaller cross-sectional area, diameter and much higher articulation of the XCHANGE 30 platform are designed to allow easier access through smaller, less-invasive ports, and to enable faster and easier access to vital organs and tissue for key advanced laparoscopic procedures.
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. Cardica's technology portfolio is intended to minimize operating time and enable minimally-invasive and robot-assisted surgeries. 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 46,400 units throughout the world. In addition, Cardica is developing the Cardica® MicroCutter XCHANGE™ 30, a cartridge-based microcutter device with a five-millimeter shaft diameter, and the Cardica® MicroCutter XCHANGE™ 45, a cartridge-based microcutter device with an eight-millimeter shaft. Both MicroCutter devices are designed to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter XCHANGE 30 and XCHANGE 45 products require 510(k) review and are not yet commercially available in the U.S.
The statement in this press release that Cardica expects to introduce the MicroCutter XCHANGE 30 to the U.S. market, pending approval by the FDA is a "forward-looking statement." 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 further develop or commercialize the XCHANGE 30 due to unanticipated technical or other difficulties; that the XCHANGE 30 may face unanticipated development, regulatory, or manufacturing delays; that review by the FDA may require additional unanticipated submissions or actions on the part of Cardica; that Cardica's intellectual property rights may not provide adequate protection to enable further development of the XCHANGE 30; that surgeons may not use the XCHANGE 30 correctly, which could cause unfavorable results that may impair the acceptance of the XCHANGE 30 by other surgeons; and that Cardica may not have sufficient funds to develop 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 Current Report on Form 10-Q for the quarter ended March 31, 2013, under the caption "Risk Factors." 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.