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

Tuesday, April 1, 2008 General News
CUPERTINO, Calif., March 31 Novare Surgical Systemsannounced today the successful completion of the first NOTES appendix removalperformed using RealHand HD instruments. Santiago Horgan, M.D., professor ofsurgery and director of minimally invasive surgery, and Mark A. Talamini,M.D., professor and chair of the Department of Surgery at UC San Diego MedicalCenter removed an inflamed appendix through a patient's vagina, a first in theUnited States. Following the 50-minute procedure, the patient reported onlyminor discomfort. Removal of diseased organs through the body's naturalopenings 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, suchas the mouth or vagina, to remove a diseased organ such as an appendix orgallbladder. Only one incision is made through the belly button for thepurpose of inserting a two millimeter camera into the abdominal cavity so thesurgeons can safely access the surgical site.

Santiago Horgan, M.D., director of the UC San Diego Center for the Futureof Surgery, is a world leader in minimally invasive surgeries, havingperformed 14 of these scarless NOTES procedures in the U.S. and Argentina.Dr. Horgan cites the critical role of biotechnology companies in bringingNOTES devices into the operating room for clinical trials.

"The path to innovation is dynamic, requiring quick response from thecompanies developing the tools," said Horgan. "Partnership with industry keepsus rolling from one success to another. The evolution of surgery toincisionless techniques is on the horizon."

By avoiding major incisions through the abdomen, patients may experience aquicker recovery with less pain while reducing the risk of post operativehernias. This procedure received approval for a limited number of patients byUC San Diego's Institutional Review Board (IRB) which oversees clinicalresearch.

"Novare is proud to be associated with this milestone in the advancementof NOTES surgery, said Kerry Pope, Novare Surgical's President and ChiefExecutive Officer. "With the successful completion of this ground-breakingNOTES appendectomy, Dr. Horgan, Dr. Talamini and the UCSD team havedemonstrated that RealHand High Dexterity instruments will continue to have asignificant role in developing minimally invasive surgical therapies".

About RealHand(R) 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 provide greater dexterity and controlaround critical structures and vasculature. The dynamic movement makes iteasy to actively manipulate and complete tasks regardless of whether theinstrument is positioned over, under, or around structures. The increase inrange of motion is leading the way for the development of new minimallyinvasive surgical approaches and techniques. RealHand instruments havereceived 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 and represe
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