Surgical devices maker
Cardica
(
CRDC
) has commenced enrolling patients in a European clinical trial
designed to evaluate its Microcutter product line. The company is
developing the Microcutter line of novel endoscopic stapling
devices for use in a variety of surgeries that require cutting and
stapling.
Cardica noted thatthe first batch of pati ents have been
enrolled and discharged from the first two investigational sites.
The company plans to enroll up to 200 patients across up to 10
European sites and evaluate patients at the time of discharge and
after 30 days following su rgery.
Cardica's Microcutter product line has been geared to offer
genuine multi-fire endoscopic stapling for a number of procedures,
such as thoracic, colorectal as well as general surgery.
The Microcutter line-up is expected to cut and staple on a
continuous basis thereby, permitting the surgeon to complete
consecutive deployments without removing the device to reload the
cartridge. The Microcutter XPRESS 30 is the first product in the
Microcutter family which Cardica intends to market. The company is
also developing the MicroCutter XCHANGE 30, a cartridge based
microcutter device.
The single-arm, multi-center trial is evaluating safety outcomes
of the MicroCutter XPRESS 30 and the MicroCutter XCHANGE 30
devices. The MicroCutter devices will be used for transections,
resections and anastomoses during gastrointestinal procedures.
Data from this study will be compared with historical adverse
results (including events such as staple line leakage, bleeding and
infections) for similar procedures executed with existing stapling
devices. Cardica plans to include the results of this trial in its
application to the U.S. Food and Drug Administration ("FDA") for
the commercialization of the MicroCutter devices.
Cardica makes stapling devices for endoscopic and cardiac
surgery procedures. Its proprietary technology is designed to
reduce operating time and enable minimally-invasive and
robot-assisted surgeries.
The company markets its automated anastomosis systems for CABG
surgery and has sold over 37,000 units globally. Cardica competes
with larger players such as
Johnson & Johnson
(
JNJ
) and
Covidien
(
COV
) in the laparoscopic stapling and sealing devices market.
Cardiac, in September 2011, cut a distribution deal with Century
Medical, a leading supplier of medical equipment in Japan, for its
Microcutter product line. The agreement provides Century Medical
with exclusive rights to distribute the Microcutter products in
Japan.
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