First Patient of NOTES Investigational Device Exemption (IDE) Study Successfully Treated With Ethicon Endo-Surgery Devices
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
"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
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
"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
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.
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.