Cardica Announces First Procedures in U.S. Using MicroCutter XCHANGE® 30 Following Expanded FDA Indication
April 18 2016 - 08:00AM
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 30The 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.
About CardicaCardica 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.
Forward-Looking StatementsThe 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.
Contact:
Investors:
Bob Newell
Vice President, Finance and Chief Financial Officer
(650) 331-7133
investors@cardica.com
Media:
Jessica Volchok
(310) 849-7985
jessica@nicoleosmer.com