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Ethicon Endo-Surgery Announces Successful Treatment Of The First Patient In IDE Feasibility Trial

Ethicon Endo-Surgery, Inc. announced that a first patient was successfully treated in its IDE feasibility trial. The case marks the first natural orifice translumenal endoscopic surgery (NOTES) procedure involving the Ethicon 's investigational devices. The procedure was performed at The Ohio State University Center for Minimally Invasive Surgery. 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.

NOTES is a surgical method where external incisions are eliminated, which lead to a quicker recovery, reduced pain and a faster return to normal activities for the patient. The Ethicon Endo-Surgery Toolbox for natural orifice surgery is a new, comprehensive suite of devices intended for this new approach to surgery. Many of these devices are featured in studies accepted for presentation at the 4th International NOSCAR Conference on NOTES. The patient who was treated at The Ohio State University Medical Center underwent a transgastric diagnostic peritoneoscopy with laparoscopic assistance before undergoing a laparoscopic gastric bypass procedure. The transgastric diagnostic peritoneoscopy is an exploratory surgery of the abdomen with the potential to treat adhesions and biopsy.

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 will include up to 40 subjects undergoing either a cholecystectomy (gallbladder removal) or diagnostic peritoneoscopy. Surgeons would perform one of four different NOTES procedures supplemented with laparoscopic assistance. The study is also designed to collect qualitative outcomes data and healthcare economic variables. Northwestern University Feinberg School of Medicine; University of California – San Diego Medical Center; and the University of Missouri University Hospital are the other three sites participating in the trial.

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.