REDWOOD CITY, Calif., June 30, 2011 /PRNewswire/ — Cardica,
Inc. (Nasdaq:
CRDC) today announced that it has completed the internal design
verification process for its proprietary Microcutter XPRESS™
30 surgical cutting and stapling device necessary to apply the CE
Mark to this product for commercial use in Europe. Cardica plans to
initiate first-in-man use of the XPRESS 30 in selected European
centers starting in July.
“Our internal verification process is both rigorous and
comprehensive, intended to comply with all regulatory requirements
in the United States and Europe. We are pleased to have
successfully accomplished this critical step toward the
commercialization of our XPRESS 30 device in Europe,” said Bernard
A. Hausen, M.D., Ph.D., president and chief executive officer of
Cardica. “With this milestone complete, we have scheduled several
laparoscopic cases in Europe using the XPRESS 30, our first true
multi-fire microcutter device that we plan to commercialize.”
About Cardica’s Microcutter Product Line
Cardica’s Microcutter surgical cutting and stapling product line
is designed to provide true multi-fire endoscopic stapling in a
variety of procedures, including colorectal, thoracic and general
surgery. The Microcutter product line is designed to cut and staple
continuously, allowing a surgeon to complete successive deployments
without removing the device for a cartridge reload. The first
device that Cardica intends to commercialize in its Microcutter
product line, the Microcutter XPRESS™ 30, has a shaft that is
8 mm in diameter, compared to commercialized stapling products with
shafts that are at least 12 mm in diameter. The smaller diameter of
the anticipated Microcutter line allows access through smaller,
less-invasive ports and, importantly, through trocars used for the
other surgical tools required for laparoscopic procedures.
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