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Novare Surgical Systems, Inc. Announces First Transvaginal NOTES Gallbladder Removals Using RealHand(TM) HD Instruments


9/13/2007 8:54:49 AM

CUPERTINO, Calif., Sept. 13 /PRNewswire/ -- Novare Surgical Systems announced today the successful completion of the first NOTES gallbladder removal procedures 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 performed California's first NOTES surgery on a 42-year old San Diego resident. Her gallbladder was removed through the vagina during a 1.5 hour procedure. UC San Diego Medical Center is the second U.S.-based hospital to perform transvaginal NOTES and the first to employ a unique technique that requires only one additional small incision placed through the belly button. This procedure received approval for a limited number of patients by UC San Diego's Institutional Review Board (IRB) which oversees clinical research.

RealHand HD instruments also were utilized in two recent transvaginal NOTES procedures that Dr. Horgan successfully completed under an Institutional Review Board (IRB) approval at the University Hospital in Buenos Aires, Argentina.

"We are extremely pleased with what we have been able to accomplish thus far and see this as an important milestone in offering patients surgical therapies that present the potential for swifter recovery, less scarring and less post operative pain," said Dr. Horgan. "The RealHand High Dexterity (HD) instrumentation was absolutely critical and allowed us to obtain the necessary mobility and control to effectively perform these operations," continued Dr. Horgan.

NOTES (Natural Orifice Transluminal Endoscopic Surgery) is an emerging surgical approach which aims to utilize the body's natural openings, such as the mouth, rectum or vagina as a conduit for an operation. Dr. Horgan's transvaginal NOTES procedures were the first such cases that only two surgical ports were necessary: one in the belly button and another through the vagina, thereby hiding any visible scaring.

"Dr. Horgan and his team have demonstrated how the enhanced dexterity and control of RealHand HD instruments enable NOTES procedures and the ongoing critical need for this advanced instrumentation," said Kerry Pope, Novare Surgical's President and Chief Executive Officer. "Novare is committed to such minimally invasive surgical therapies which offer clear patient advantages, particularly post operative pain reduction and excellent cosmetic results."

About RealHand(TM) 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 make it easy to actively manipulate and complete tasks regardless of whether the instrument is positioned over, under, or around structures.

RealHand HD instruments will provide for greater dexterity and control around critical structures and vasculature. The increase in range of motion will lead the way for development of new 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 www.novaresurgical.com.

Novare Surgical Systems

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


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