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Novare Surgical Systems, Inc. Announces First Transvaginal NOTES Appendix Removal Using RealHand(R) HD Instruments


3/31/2008 8:03:00 AM

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.

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

Web site: http://www.novaresurgical.com/



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