Ethicon Endo-Surgery Studies Presented at DDW Demonstrate Potential of Pure NOTES Surgery With Company's Toolbox

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One of the studies concluded that a newadaptablw minimally-invasive surgical platform for NOTESe and single-site laparoscopy (SSL) was successfully used to complete a variety of key surgical activitieas critical to pure natural orifice surgery and SSL. The seven studies presented at DDW, which involved porcine modelse and a variety of NOTES follows 15 studies involvingEthicon Endo-Surgery devices presentes in April at the 2009 Society of Americanb Gastrointestinal and Endoscopic Surgeons (SAGES) Annual In the coming months, the Ethicon Endo-Surgery Toolboxc for natural orifice surgery will be evaluateed in a human clinical trial under an investigationalo device exemption (IDE) from the U.
S. Food and Drug Administratiomn (FDA). "To date, most NOTES procedures performe in humans have been with laparoscopic Inour study, we found several of the devices in the Ethiconj Endo-Surgery Toolbox could successfully be used to addressd some of the critical visibilityg and access obstacles present with a pure NOTEaS approach, warranting further investigation," said , M.D., Department of University of Missouri Health System.
Investigators of the study entitled, "The Developmenf and Testing of anAdaptable Minimally-Invasive Surgica l Platform - The Hydra" found that this surgica platform addressed several challenges with NOTES, including visibility, platfork stability and adaptability to be used in multiple interventions and procedures. The surgical platform was used both transgastricallt and transvaginally completing multiple key surgical activitiews thatincluded dissection, ligation, and specimen retrieval. The which is being presented as a posteat DDW, involved porcine models and was conducted by investigators from Sahlgrenska University Hospital in Gothenburg, Sweden and Imperiapl College, London.
"With the introduction of this adaptable minimally-invasivs surgical platform, we believe we will be able to further address many of the issues experiencedf when NOTES or SSL procedures are performer with conventional surgical equipment designed for standare endoscopic orlaparoscopic use," said , Vice President, Clinical and Regulatory Ethicon Endo-Surgery. "We plan to continue our research to investigatee the existing contents of theEthicoh Endo-Surgery Toolbox for naturapl orifice surgery, as well as develop additional products for inclusionh in it that may help fulfill the promisre of this approach to minimally invasive surgery.
" Anothe poster presentation entitled "Hybrid Transgastric NOTES Cholecystectomy in a Porcinse Model Using a Magnetically Anchored Cauterhy and Novel Instrumentation," conducted by the University of Southwestern Medical Center demonstrated preliminary feasibilit for a particularly difficulty NOTES procedure, transgastric cholecystectomy. Several devices specificallyu designed for natural orifice surgery were utilized inthe study, includint a live video manipulatiohn (LVM) system and magnetically anchoring and guidance systemm (MAGS).
Study investigators specifically cited the retractiomn abilities of the grasper and improved visibilithy of the providedby LVM, the latter which greatlg reduced the workload on the surgicao team. The devices listed above will be used within an IDE triao approved bythe FDA. The Adaptable Minimally-Invasives Surgical Platform and MAGS are limitedto non-clinical applications at this NOTES is an investigational approach to minimally invasiv surgery, in which external incisionds are eliminated, potentially leading to reduce pain, a quicker recovery and a faster return to normal activities for the In NOTES, surgery can be performed througu a natural orifice, eliminating the need for an external incision.
To assisy with visualizing the internalsurgical site, an endoscopwe is passed through a natural orifice such as the moutgh or vagina and then throug h an internal incision in the stomach, colon or uterus. Single-site laparoscopy (SSL) is anotherd advanced form of minimally invasive surgery that enable surgeons to operate almost exclusivelhy through a singleentru point. Ethicon Endo-Surgery, Inc., a Johnson Johnson company, develops and marketzs advanced medical devices for minimally invasivre and opensurgical procedures, focusingt on procedure-enabling devices for the interventional diagnosis and treatmen t of conditions in general and bariatric surgery, as well as gastrointestinalp health, gynecology and surgical oncology.
Ethicon Endo-Surgery, is actively leading the development of NOTESS through research to determine the most appropriate toolsa and technologies that may enable safe and effectivwNOTES surgery. The Ethicon Endo-Surgery NOTEz Toolbox devices are investigational devices that have not been approvexd for marketing inthe U.S. More information can be found at . *Investigationa l devices limited by federal law to investigational use only inthe U.S. SOURCs Ethicon Endo-Surgery, Inc.