Cardica, Inc. CRDC today announced that it filed regulatory documents with the U.S. Food
and Drug Administration (FDA) for marketing clearance of the MicroCutter
XCHANGE™ 30, a cutting and stapling device designed to be used in multiple
open and minimally invasive surgical procedures. The XCHANGE 30 has a
cross-sectional area six times smaller than conventional surgical staplers and
articulates up to 80 degrees in each direction. The lower profile provides
greater access through a 5 mm trocar.
The submission to the FDA includes the results of Cardica's recently completed
MicroCutter European Trial (MET1). In the MET1 study, the MicroCutter XCHANGE
30 met the primary endpoint, freedom of MicroCutter-related severe adverse
events when compared to historical controls from the medical literature, with
only one event in 160 patients enrolled and 423 deployments.
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