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FDA Grants Ethicon Endo-Surgery Approval of Its IDE Application to Commence Study of Notes Toolbox(TM)
Date:4/22/2009

CINCINNATI, April 22 /PRNewswire/ -- Ethicon Endo-Surgery today announced that the U.S. Food and Drug Administration (FDA) granted approval of the company's Investigational Device Exemption (IDE) application to conduct the first study of devices designed for use in natural orifice translumenal endoscopic surgery (NOTES). The company is the first to receive an IDE to investigate devices specifically designed for natural orifice surgery. The feasibility trial will primarily evaluate the safety of the Ethicon Endo-Surgery NOTES Toolbox(TM), a comprehensive suite of devices specifically designed for this new approach to surgery. NOTES is a surgical procedure in which external incisions are eliminated.

The study will include up to 40 subjects undergoing either a cholecystectomy (gallbladder removal) or diagnostic peritoneoscopy (exploratory surgery to investigate chronic pelvic pain). Surgeons will use one of four different NOTES techniques supplemented with laparoscopic assistance. In addition to evaluating the safety of the Ethicon Endo-Surgery NOTES Toolbox, the study is also designed to collect qualitative outcomes data and healthcare economic variables.

"This trial marks an important step in the continued effort to improve surgery for patients and reduce the overall trauma to the body," said Eric Hungness, MD, Northwestern University. "The contributions of the medical device industry are critical to advancing NOTES, and I applaud Ethicon Endo-Surgery for creating and studying the tools surgeons need to realize the potential benefits of this new and promising type of surgery."

During NOTES, an endoscope is passed through a natural orifice (e.g., mouth, vagina) then through an internal incision in the stomach, bladder, colon or uterus, thus avoiding any external incisions or scars.

"We are excited about the potential benefits of NOTES to patients and the o
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SOURCE Ethicon Endo-Surgery
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