Cardica Issues Voluntary Removal of MicroCutter XCHANGE(R) 30 Blue Cartridge
November 19 2015 - 4:05PM
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.
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 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.
Forward-Looking StatementsThe 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
investors@cardica.com