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Novare Announces First Transvaginal NOTES Gallbladder Removals Using RealHand(TM) HD Instruments

Friday, September 14, 2007 General News
CUPERTINO, Calif., Sept. 13 Novare Surgical Systemsannounced today the successful completion of the first NOTES gallbladderremoval procedures performed using RealHand HD instruments. Santiago Horgan,M.D., professor of surgery and director of minimally invasive surgery, andMark A. Talamini, M.D., professor and chair of the Department of Surgery at UCSan Diego Medical Center performed California's first NOTES surgery on a42-year old San Diego resident. Her gallbladder was removed through the vaginaduring a 1.5 hour procedure. UC San Diego Medical Center is the secondU.S.-based hospital to perform transvaginal NOTES and the first to employ aunique technique that requires only one additional small incision placedthrough the belly button. This procedure received approval for a limitednumber of patients by UC San Diego's Institutional Review Board (IRB) whichoversees clinical research.

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

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

NOTES (Natural Orifice Transluminal Endoscopic Surgery) is an emergingsurgical approach which aims to utilize the body's natural openings, such asthe mouth, rectum or vagina as a conduit for an operation. Dr. Horgan'stransvaginal NOTES procedures were the first such cases that only two surgicalports 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 andcontrol of RealHand HD instruments enable NOTES procedures and the ongoingcritical need for this advanced instrumentation," said Kerry Pope, NovareSurgical's President and Chief Executive Officer. "Novare is committed to suchminimally 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 InvasiveSurgery

RealHand HD instruments are the very first full range of motion hand-heldlaparoscopic instruments. Developed with the EndoLink(R) mechanism, RealHandtechnology is designed to mirror the surgeon's hand direction with the addedbenefit of tactile feedback. As such, when the surgeon's hand moves in onedirection, the instrument tip exactly follows.

Unlike standard laparoscopic instrumentation, RealHand offers complete 7degrees of freedom of movement in a hand-held instrument and with no need foradditional hardware. Moreover, RealHand will enable surgeons to perform moredifficult maneuvers that otherwise cannot be completed with traditional rigidinstruments. RealHand HD instruments make it easy to actively manipulate andcomplete tasks regardless of whether the instrument is positioned over, under,or around structures.

RealHand HD instruments will provide for greater dexterity and controlaround critical structures and vasculature. The increase in range of motionwill 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 originallyfounded in 1999 to develop, manufacture and market devices for cardiacsurgery. RealHand was developed entirely at Novare Surgical
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