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

CINCINNATI, July 9 /PRNewswire/ -- Ethicon Endo-Surgery, Inc. today announced the successful treatment of the first patient of its IDE feasibility trial. The case, which was performed at The Ohio State University Center for Minimally Invasive Surgery, marks the first natural orifice translumenal endoscopic surgery (NOTES) procedure involving the company's investigational devices. NOTES is a surgical method in which external incisions are eliminated, potentially leading to reduced pain, a quicker recovery and a faster return to normal activities for the patient.

The Ethicon Endo-Surgery Toolbox* for natural orifice surgery is a novel, comprehensive suite of devices specifically designed for this new approach to surgery. Several of these devices are featured in studies accepted for presentation this week at the 4th International NOSCAR Conference on NOTES in Boston. The patient treated at The Ohio State University Medical Center underwent a transgastric diagnostic peritoneoscopy with laparoscopic assistance prior to a laparoscopic gastric bypass procedure. The transgastric diagnostic peritoneoscopy is an exploratory surgery of the abdomen with the potential to treat adhesions, biopsy, etc.

"Using the Ethicon Endo-Surgery Toolbox, we were able to perform a thorough diagnostic peritoneoscopy in about the same timeframe as a typical laparoscopic procedure using the patient's mouth as the primary external access point. This protocol was designed to collect device data as well as intra-operative procedure data on the Ethicon Endo-Surgery Toolbox to assess the feasibility of using these devices within this procedural application," said Jeffrey Hazey, MD, FACS, assistant professor at the Ohio State University Center for Minimally Invasive Surgery. "I believe this study will serve as a critical step in advancing NOTES and NOTES specific technology, which holds great promise for improving surgery 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
  • Articulating Biopsy Forceps

The devices listed above will be used within an IDE trial approved by the FDA, they are not currently cleared by FDA for commercial distribution.

About NOTES

NOTES is an 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.

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.


'/>"/>
SOURCE Ethicon Endo-Surgery, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
3. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
4. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
5. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
6. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
7. Tainted Chinese Food Ingredients First Discovered in 2005
8. First Patient Enrolled in Europe in Ovature Phase III Ovarian Cancer Trial
9. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
10. Human Genome Sciences Completes Enrollment of First Phase 3 Albuferon(R) Trial Ahead of Schedule
11. Opko Health Doses First Patient in Phase 3 COBALT Trial of Bevasiranib for the Treatment of AMD
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... 8, 2016 According to ... by Product (Actual Sugars, Sugar Alcohols, Artificial Sweeteners), ... Tonicity Agents), Formulation (Oral, Topical, Parenteral) - Global ... has witnessed healthy growth during the last decade, ... of 4.3% between 2016 and 2021 to reach ...
(Date:12/8/2016)... December 8, 2016 According to a new market ... Sleep, Fetal), Therapeutic (Pain, Insulin)), End Use (Sports, Fitness, RPM), Type (Smart ... MarketsandMarkets, the global market, in terms of value, is projected to reach ... CAGR of 18.0% during the forecast period. ... ...
(Date:12/8/2016)... , Dec. 8, 2016  Hanson Research, ... of dissolution testing and diffusion testing instruments for ... acquired by Teledyne Instruments, Inc. ("Teledyne"). The move ... line of precision testing instruments, as well as ... development of new products and services. ...
Breaking Medicine Technology:
(Date:12/8/2016)... ... December 08, 2016 , ... Seavest Healthcare Properties ... by an affiliate of Seavest, has won a prestigious national healthcare real estate ... ambulatory care center (ACC) was named “Best New Development, MOBs and Other Outpatient ...
(Date:12/8/2016)... ... ... David J. Dykeman , Ginger Pigott , and J. Rick Taché ... Dec. 12, 2016, at the Fairmont Newport Beach in California. Greenberg Traurig is a ... & Medical Technology Group have been featured speakers at every DeviceTalks conference since 2011. ...
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... ... technologies and development solutions for drugs, biologics and consumer health products, today announced ... was set up in 2006 as a non-profit organization to unite pharmaceutical and ...
(Date:12/8/2016)... ... December 08, 2016 , ... Today’s patients are encouraged to ... mind, SIGVARIS has created a new line of anti-embolism stockings to help prevent ... the benefits of graduated compression when transitioning from recovery to early rehabilitation. , ...
(Date:12/8/2016)... ... 08, 2016 , ... The Dianne Michael Insurance Agency, an ... County, is embarking on a charity drive with the aim of generating support ... orphaned or neglected senior dogs in the Cincinnati region, and LuvFurMutts volunteers also ...
Breaking Medicine News(10 mins):