Navigation Links
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 overall healthcare industry," said Karen Licitra, Company Group Chairperson, Ethicon Endo-Surgery. "An integral piece to advancing NOTES surgery responsibly is ensuring surgeons have the proper technology at hand. This IDE represents an important step for Ethicon Endo-Surgery in fulfilling that need by pursuing a NOTES-specific indication for the NOTES Toolbox."

The four sites participating in the trial include Northwestern University Feinberg School of Medicine; University of California - San Diego Medical Center; The Ohio State University Center for Minimally Invasive Surgery; and the University of Missouri University Hospital. Each clinical trial site will investigate one of four methods: transgastric (through the mouth) and transvaginal (through the vagina) cholecystectomies and transgastric and transvaginal diagnostic peritoneoscopies.

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.


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

Related medicine news :

1. U.S. Labor Department Awards $10.1 Million for Safety and Health Training Grants
2. Sunesis Pharmaceuticals Reports New Option Grants Under NASDAQ Marketplace Rule 4350
3. American Cancer Society awards research grants to 109 investigators at 77 institutions nationwide
4. USAID Announces First Malaria Communities Program Grants
5. The Highmark Foundation Awards $580,000 in Highmark Healthy High 5 Grants to Four Non-Profit Organizations
6. KV Pharmaceutical Company Reports Results of Special Independent Committee Review of Stock Option Grants
7. FDA Grants Clearance to Langford IC Systems, Inc.
8. Dienst Custom Homes Grants Over 40 Wishes in Three Years
9. United Animal Nations Offers Financial Assistance Grants of up to $500 to Help Southern California Fire Victims Obtain Vet Care, Temporary Boarding for Pets
10. PA Health Department Awards Community Primary Care Challenge Grants
11. FDA Grants Kiadis Pharma Lead Product ATIR Orphan Drug Designation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a ... can give their videos a whole new perspective by using the title layers ... Film Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Conventional wisdom preaches ... success. In terms of the latter, setting the bar too high can result in ... than just slow progress toward their goal. , Research from PsychTests.com ...
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- The Academy of Managed Care Pharmacy (AMCP) today ... allow biopharmaceutical companies to more easily share health care ... coverage decisions, a move that addresses the growing need ... The recommendations address restrictions in the sharing of product ... a prohibition that hinders decision makers from accessing HCEI ...
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ... company developing innovative inhaled drugs, announced today that it ... Russell Investments reconstituted its comprehensive set of U.S. ... "This is an important milestone for Pulmatrix," said ... increase shareholder awareness of our progress in developing drugs ...
(Date:6/23/2016)... 23, 2016 Any dentist who has made an ... current process. Many of them do not even offer this ... and high laboratory costs involved. And those who ARE able ... such a high cost that the majority of today,s patients ... Parsa Zadeh , founder of Dental Evolutions Inc. and ...
Breaking Medicine Technology: