Cardica Receives FDA Clearance for Multiple Expanded Indications of World’s Smallest-Profile Articulating Surgical Stapling...
January 19 2016 - 8:00AM
Cardica, Inc. (Nasdaq:CRDC) today announced the company has
received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) to use its MicroCutter XCHANGE® 30 surgical
stapling device with a white cartridge for the transection and
resection in open or minimally invasive urologic, thoracic, and
pediatric surgical procedures. This clearance complements the
existing indications for use of the MicroCutter XCHANGE 30 in
surgical procedures in the small and large intestine and in the
appendix.
Surgical staplers are routinely used in the U.S. in more than
one million minimally invasive or robotically-assisted laparoscopic
surgical procedures annually. At five millimeters and
articulating to 80 degrees, the MicroCutter XCHANGE 30 is the
smallest-profile articulating stapler available in the world.
It is currently available with a white cartridge used to staple
vascular and other thin tissue.
“With this important corporate and commercial milestone, the
MicroCutter’s U.S. indication covers many of the same indications
as approved in the European Union,” said Julian Nikolchev,
president and CEO of Cardica. “We look forward to introducing this
innovative surgical stapler in a limited launch to key opinion
leaders throughout the United States, including those surgeons
performing video assisted thoracic surgery (VATS) at the annual
meeting of the Society of Thoracic Surgeons (STS) in Phoenix,
Arizona later this month and leading pediatric surgeons at the
American Pediatric Surgical Association annual meeting in San Diego
in May 2016.”
Mr. Nikolchev continued, “Importantly, our primary company focus
will remain the completion of the development for our new
combination device, while we optimize our supply chain to ensure
adequate supply of the combination device at product launch.”
About the MicroCutter XCHANGE 30
The 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
small size and large degree of articulation enhances the surgeon’s
access and visualization at the surgical site. This device is
designed 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 may reduce the amount of dissection and
tissue handling required to position the stapler in confined
spaces, enabling access to difficult to reach
anatomy.
About Cardica
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, 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 Statements
The 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, 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 the combination device or
achieve optimization of the Company’s supply chain for the
combination device; 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