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November 21, 1997
General Surgical Innovations Receives 510K Approval to Market
Its Dissector/Expander Device
CUPERTINO, Calif., Nov. 21 /PRNewswire/(Nasdaq: GSII) -- General Surgical Innovations, Inc. announced today that it
has received 510(k) marketing clearance from the United States
Food and Drug Administration (FDA) for its combination Dissector/Expander.
This innovative device integrates the Company's proprietary balloon
dissector with a traditional tissue expander into one device,
which the Company believes will enable surgeons to perform faster
and easier tissue expansion procedures.
More than 60,000 tissue expansion procedures were performed worldwide
in 1996. Tissue expansion is employed by plastic and reconstructive
surgeons to create additional skin to repair functional or cosmetic
skin defects. Current tissue expansion procedures require large
incisions and blunt dissection to create space for a tissue expander.
The incision typically requires one to three weeks to heal after
which the surgeon begins incrementally filling the tissue expander,
stretching the overlying skin. In contrast to the traditional
method, GSI's Dissector/Expander provides an all-in-one device
which allows the surgeon to dissect a predictable space and, through
a small incision up to six centimeters from the expansion site,
remotely deploy a tissue expander in one step. This remote incision
allows for the im../mediate commencement of expansion versus the
typical weeks' delay associated with standard tissue expanders,
eliminating the trauma of a large incision and the associated
one to three weeks of healing time. The Company anticipates that
the reduced overall procedure time, smaller incision, and im../mediate
commencement of expansion will lower the overall cost and provide
a more appealing clinical option for patients.
``We believe the combined Dissector/Expander technology is a revolutionary
improvement to traditional tissue expansion. This device can be
used anywhere that additional skin is needed, including such procedures
as breast reconstruction, scar revision and treatment of male
pattern baldness,'' stated Gregory D. Casciaro, President and
Chief Operating Officer of GSI. ``We believe that the GSI Dissector/Expander
allows surgeons to perform a procedure which provides significant
clinical benefits to patients including reduced procedure and
recovery time. We are excited about bringing the benefits of this
technology to a broad group of patients.''
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