Cardica Submits Additional Documentation to FDA in Support of 510(k) Submission
December 16 2015 - 8:00AM
Cardica, Inc. (Nasdaq:CRDC) today announced that it submitted its
responses to the questions raised by the U.S. Food and Drug
Administration (FDA) on Cardica’s 510(k) submission for an expanded
Indication for Use for the MicroCutter XCHANGE® 30. The responses
to the FDA included the results from Cardica’s new chronic animal
study conducted specifically in response to one of the FDA’s
questions.
About CardicaCardica 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, 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 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.
Contact:
Bob Newell
Vice President, Finance and Chief Financial Officer
(650) 331-7133
investors@cardica.com