CincinNAti, April 22 /PRNewswire/ -- Ethicon Endo-Surgery today announced the company's novel, investigational* devices, including its NOTES Toolbox(TM), are featured in 15 studies being presented at the 2009 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Annual Meeting. Setting the stage for human trials, 13 of the studies reported positive preliminary experiences with the devices during, or with direct application to, natural orifice translumenal endoscopic surgery (NOTES). Two additional studies demonstrated a new multi-port device developed by Ethicon-Endo Surgery successfully facilitated single-site laparoscopy (SSL).
"The development of new technology will be integral in order to safely and responsibly move SSL and NOTES forward," said Daniel J. Scott MD, FACS, associate professor of surgery, University of Texas Southwestern Medical School. "In particular, we found the natural orifice surgery devices developed by Ethicon Endo-Surgery addressed some fundamental limitations of the off-the-shelf endoscopic instruments used in NOTES procedures to date. These new devices overcome some of the force limitations typical of flexible devices and may provide the operating clinician capabilities that are more in line with laparoscopy."
The NOTES Toolbox is a comprehensive suite of devices specifically designed for natural orifice surgery. Highlights of the NOTES Toolbox studies presented at the 2009 SAGES Annual Meeting include:
- The Development and Testing of a Tethered, Independent Camera for NOTES and Single-Site Laparoscopic Procedures (Podium Presentation) - Found a newly developed displaced visualization system provided surgeons a "stadium view" similar to that of a laparoscope during preclinical NOTES procedures in the porcine model. Study authors, led by Imperial College (London) and Colchester General Hospital (United Kingdom), believe the system could help overcome visualization challenges and instrument congestion associated with NOTES and SSL.
- A New NOTES Toolbox: Flexible Instruments for Translumenal Surgery (Emerging Tech Podium Presentation) - The study investigators concluded the NOTES Toolbox greatly expands the capabilities of the endoscope and will serve as an excellent foundation for future innovations. This study, in which the NOTES Toolbox was used in a porcine model, was conducted by doctors at Dartmouth-Hitchcock Medical Center, Sahlgrenska University Hospital (Goteborg, Sweden) and Imperial College (London).
- Tissue Apposition System (TAS) - New Technology to Minimize Surgery for Endoscopically Unresectable Colonic Polyps (Podium Presentation) - Concluded the TAS, a novel technology developed by Ethicon Endo-Surgery for the endoscopic placement of sutures, can be used safely to close a defect in the colon under laparoscopic control. Doctors from the University Hospitals Case Medical Center conducted this study, which included seven patients. Ethicon Endo-Surgery plans to investigate the use of the TAS in NOTES procedures next.
- Transgastric Uterine Horn Resection Using a Novel NOTES Toolbox (Podium Presentation) - Successfully simulated a pure NOTES appendectomy in a porcine model using the NOTES Toolbox. Doctors at Northwestern University Feinberg School of Medicine led this study.
- Completely Transvaginal NOTES Cholecystectomy in a Porcine Model Using Novel Endoscopic Instrumentation (Poster Presentation) - Concluded a pure NOTES cholecystectomy (gall bladder removal), without any laparoscopic assistance, is feasible in a porcine model using the NOTES Toolbox. To date, transvaginal cholecystectomy is the most common NOTES procedure performed in humans. The study was led by doctors at Southwestern Center for Minimally Invasive Surgery, University of Texas Southwestern Medical Center.
- A Novel Flexible Endoscopic Clip Applier Overcomes the Shortcomings of Currently Used Ligation Clips for NOTES (Emerging Tech Poster Presentation) - Determined that the Flexible Ligating Clip Applier quickly and precisely places true, zero-gap, ligating clips - the first flexible device of its kind to do so. The study, which involved porcine models, was led by doctors at the University of California, San Diego.
In the coming months, the NOTES Toolbox will be evaluated in a feasibility trial under an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA). The content of the NOTES 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
- Articulating Biopsy Forceps
About NOTES and SSL
NOTES is a new, investigational approach to minimally invasive surgery, in which external incisions are eliminated, potentially leading to reduced pain, a quicker recovery and a faster return to normal activities for the patient. In NOTES, surgery can be performed through a natural orifice, eliminating the need for an external incision. To assist with visualizing the internal surgical site, an endoscope is passed through a natural orifice such as the mouth or vagina and then through an internal incision in the stomach, bladder, colon or uterus.
Single-site laparoscopy (SSL) is another advanced form of minimally invasive surgery that enables surgeons to operate almost exclusively through a single entry point.
About Ethicon Endo-Surgery
Ethicon Endo-Surgery, a Johnson & Johnson company, develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology.
Ethicon Endo-Surgery is actively leading the development of NOTES through research to determine the most appropriate tools and technologies that may enable safe and effective NOTES surgery. The Ethicon Endo-Surgery NOTES Toolbox devices are investigational devices that have not been approved for marketing in the U.S. More information can be found at www.ethiconendo.com.
*Investigational devices limited by federal law to investigational use only in the U.S.
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