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First Patient of NOTES Investigational Device Exemption (IDE) Study Successfully Treated With Ethicon Endo-Surgery Devices
Date:7/9/2009

ry for both patients and physicians."

The study, which is the first to receive an investigational device exemption (IDE) to study devices for NOTES, will include up to 40 subjects undergoing either a diagnostic peritoneoscopy or cholecystectomy (gallbladder removal). Surgeons will use one of four different NOTES procedures supplemented with laparoscopic assistance. In addition to evaluating the feasibility of the Ethicon Endo-Surgery Toolbox for natural orifice surgery, the study is also designed to collect qualitative outcomes data and healthcare economic variables. The other three sites participating in the trial include Northwestern University Feinberg School of Medicine; University of California - San Diego Medical Center; and the University of Missouri University Hospital.

"The success of the first case of the IDE study and the associated data presentations at NOSCAR are important contributions in a growing body of evidence that demonstrates the promise of the Ethicon Endo-Surgery Toolbox for natural orifice surgery," said Kenneth Sumner, PhD, vice president, clinical and regulatory affairs, Ethicon Endo-Surgery. "We believe NOTES has enormous potential and Ethicon Endo-Surgery is committed to working with leading medical intuitions and societies, which we believe is essential to responsibly and effectively move natural orifice surgery forward."

About the Ethicon Endo-Surgery Toolbox for Natural Orifice Surgery*

The content of the investigational Ethicon Endo-Surgery Toolbox includes:

  • Tissue Apposition System
  • Steerable Flex Trocar with Rotary Access Needle
  • Flexible Bipolar Hemostasis Forceps
  • Flexible Maryland Dissector
  • Articulating Hook Knife
  • Articulating Snare
  • Articulating Needle Knife
  • Articulating Graspers
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SOURCE Ethicon Endo-Surgery, Inc.
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