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January 27, 1998 Cupertino, CA -- January 27, 1998 --General Surgical Innovations,
Inc. (GSI) (Nasdaq: GSII) announced today that it has received 510(k) clearance from the
U.S. Food and Drug Administration (FDA) that expands the indications
for use of the company's proprietary SPACEMAKER® surgical balloon dissection products in minimally invasive surgical
procedures. Specifically, the SPACEMAKER® surgical balloon dissection products are now cleared for use
in surgeries that involve access to the spine and long-bone plating,
as well as thoracoscopic procedures involving exposure and dissection
of nerves, blood vessels and other tissues of the chest wall.
For those procedures involving cardiovascular applications, the
product will be marketed through GSI's Cardiovascular Group; all
other applications will be marketed through the company's Technology
Alliance Group. Gregory Casciaro, President and Chief Operating Officer of GSI,
stated, "This clearance to market our SPACEMAKER® surgical balloon dissection products in these new indications
enables us to move forward in all of our key target markets. The
company believes that physicians, as well as its distributors,
are looking for ways to convert these traumatic open procedures
to less invasive, less traumatic methods. The SPACEMAKER® products help address the needs of surgeons in performing these
minimally invasive procedures. This approval is another important
step in the conversion of traditional major open procedures into
less invasive surgeries that often involve shorter patient recovery
periods and are more cost effective." GSI's patented SPACEMAKER® tissue dissection systems, based on the company's patented balloon
technology, more rapidly and gently create surgical working spaces
by separating natural tissue planes without resorting to blunt
dissection used in conventional open surgery or minimally invasive
surgery conducted outside of a natural body cavity. In procedures
using SPACEMAKER® dissectors, a surgeon creates a small incision through which
the balloon is inserted and placed between naturally occurring
tissue layers such as muscle, fat and skin. Subsequently, the
balloon is filled to a specific volume with air or saline, causing
the desired dissection of the tissue planes. The balloon is then
removed and the dissected space can be insufflated to open the
surgical operating space created by the use of the SPACEMAKER® system. Headquartered in Cupertino, California, General Surgical Innovations,
Inc. develops, manufactures and sells tissue dissection systems
based on the company's patented balloon technology for minimally
invasive surgical procedures. The company's products are specifically
designed for endoscopic and laparoscopic techniques for use in
general, vascular, thoracoscopic, orthopedic, cosmetic and reconstructive
surgeries to create an operating space at the surgical site, which
the company believes lessens tissue damage and improves patient
recovery time. The company has developed a broad range of balloon
shapes and sizes to be used for various surgical techniques, procedures
and market segments. GSI distributes its products worldwide through
a network of distribution partners and a direct sales force.
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