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

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Medical Devices / Diagnostics
Article Date: 10 Jul 2009 - 2:00 PDT

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Ethicon Endo-Surgery, Inc. 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.

Source: Ethicon Endo-Surgery, In