Novare Announces First Transvaginal NOTES Appendix Removal Using RealHand(R) HD Instruments

Novare Announces First Transvaginal NOTES Appendix Removal Using RealHand(R)
HD Instruments
UC San Diego Medical Center team performs first 'hidden scar' transvaginal
NOTES appendix removal in the U.S.

CUPERTINO, Calif., March 31 /PRNewswire/ -- Novare Surgical Systems
announced today the successful completion of the first NOTES appendix removal
performed using RealHand HD instruments. Santiago Horgan, M.D., professor of
surgery and director of minimally invasive surgery, and Mark A. Talamini,
M.D., professor and chair of the Department of Surgery at UC San Diego Medical
Center removed an inflamed appendix through a patient's vagina, a first in the
United States. Following the 50-minute procedure, the patient reported only
minor discomfort. Removal of diseased organs through the body's natural
openings may offer patients a rapid recovery, minimal pain, and no scarring.
The procedure, called Natural Orifice Translumenal Endoscopic Surgery
(NOTES), involves passing surgical instruments through a natural orifice, such
as the mouth or vagina, to remove a diseased organ such as an appendix or
gallbladder. Only one incision is made through the belly button for the
purpose of inserting a two millimeter camera into the abdominal cavity so the
surgeons can safely access the surgical site.
Santiago Horgan, M.D., director of the UC San Diego Center for the Future
of Surgery, is a world leader in minimally invasive surgeries, having
performed 14 of these scarless NOTES procedures in the U.S. and Argentina.
Dr. Horgan cites the critical role of biotechnology companies in bringing
NOTES devices into the operating room for clinical trials.
"The path to innovation is dynamic, requiring quick response from the
companies developing the tools," said Horgan. "Partnership with industry keeps
us rolling from one success to another. The evolution of surgery to
incisionless techniques is on the horizon."
By avoiding major incisions through the abdomen, patients may experience a
quicker recovery with less pain while reducing the risk of post operative
hernias. This procedure received approval for a limited number of patients by
UC San Diego's Institutional Review Board (IRB) which oversees clinical
research.
"Novare is proud to be associated with this milestone in the advancement
of NOTES surgery, said Kerry Pope, Novare Surgical's President and Chief
Executive Officer. "With the successful completion of this ground-breaking
NOTES appendectomy, Dr. Horgan, Dr. Talamini and the UCSD team have
demonstrated that RealHand High Dexterity instruments will continue to have a
significant role in developing minimally invasive surgical therapies".
About RealHand(R) High Dexterity (HD) Instruments for Minimally Invasive
Surgery
RealHand HD instruments are the very first full range of motion hand-held
laparoscopic instruments. Developed with the EndoLink(R) mechanism, RealHand
technology is designed to mirror the surgeon's hand direction with the added
benefit of tactile feedback. As such, when the surgeon's hand moves in one
direction, the instrument tip exactly follows.
Unlike standard laparoscopic instrumentation, RealHand offers complete 7
degrees of freedom of movement in a hand-held instrument and with no need for
additional hardware. Moreover, RealHand will enable surgeons to perform more
difficult maneuvers that otherwise cannot be completed with traditional rigid
instruments. RealHand HD instruments provide greater dexterity and control
around critical structures and vasculature. The dynamic movement makes it
easy to actively manipulate and complete tasks regardless of whether the
instrument is positioned over, under, or around structures. The increase in
range of motion is leading the way for the development of new minimally
invasive surgical approaches and techniques. RealHand instruments have
received FDA 510(k) clearance.
About Novare Surgical Systems
Based in Cupertino, California, Novare Surgical Systems was originally
founded in 1999 to develop, manufacture and market devices for cardiac
surgery. RealHand was developed entirely at Novare Surgical and represents a
shift in the company's focus toward devices for minimally invasive surgery.
For more information, visit the company's web site at
http://www.novaresurgical.com.
SOURCE Novare Surgical Systems

Kerry Pope, President and CEO of Novare Surgical Systems Inc.,
+1-408-873-3161, kpope@novaresurgical.com