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November 20, 1997 General Surgical Innovations Announces First Commercial Use of
ENDOSAPH Vein Harvest System Performed By Hans Zwart & Associates CUPERTINO, Calif., Nov. 20 /PRNewswire/(Nasdaq: GSII) -- General Surgical Innovations, Inc. announced today that its
newest cardiovascular product, the ENDOSAPH(TM) Vein Harvest System,
was used successfully in its first commercial applications. At
the Franciscan Medical Center located in Dayton, Ohio, Hans H.
J. Zwart, MD & Associates were the first to use GSI's ENDOSAPH
system in three procedures for minimally invasive harvesting of
the saphenous vein for use in coronary artery bypass graft (CABG)
procedures. Launched in October at the American College of Surgeons meeting
in Chicago and now commercially available in the U.S., the ENDOSAPH,
GSI's second generation harvesting system, provides tools to perform
saphenous vein harvesting using minimally invasive surgical techniques.
The kit includes the SAPHfinder(TM) surgical balloon dissector,
the SPACEKEEPER(TM) retractor with a self-retaining distal hood,
and GSI's reusable Hook and Fork dissectors. Commenting on the ENDOSAPH system, Dr. Zwart, stated, ``I was
particularly impressed with the quickness of the vein harvesting
procedures and the quality of the veins received from these procedures.
I was also impressed with the self-retaining ability of the SPACEKEEPER
retractor which dramatically improved the ability to use two hands,
enabling the introduction of multiple instrumentation. We no longer
have to create large incisions in the patient's leg to harvest
a saphenous vein and by reducing the incision size, we have greatly
reduced the pain and trauma associated with this procedure thus
significantly improving recovery.'' Added Lawrence R. Tyler, RN, PAC and a member of the Zwart Cardiovascular
Surgery Group, ``The ENDOSAPH system was easy to use, particularly
quick in creating a high quality space and provided excellent
visualization of the vein during the dissection. Because of its
more hands-free approach, this system made the procedure much
easier to perform. We have tried a full range of minimally invasive
saphenous vein harvesting systems, and the ENDOSAPH is clearly
a better solution.'' GSI's President and Chief Operating Officer Gregory Casciaro stated,
``We are very pleased with the success Dr. Zwart and his group
experienced with the ENDOSAPH system. We believe the GSI system
provides significant advantages over other minimally invasive
systems and delivers a range of clinical and cost benefits to
the surgeon, patient, and payor. The worldwide market for this
product is very attractive to GSI, and we are devoting significant
resources to capitalizing on our opportunities in this area.''
In 1996, more than 600,000 CABG procedures were performed worldwide;
of those performed, nearly 90 percent in the United States and
60 percent internationally used the patient's saphenous vein as
a bypass graft. GSI's Spacemaker(R) tissue dissection systems, based on the company's
patented balloon technology, 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 system is then removed and the dissected space can be insufflated
with gas to create a surgical operating space.
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