The Food and Drug Administration has approved Ethicon Endo-Surgery???s Investigational Device Exemption (IDE) application to study the safety of Ethicon???s NOTES Toolbox, a new line of devices specifically designed for natural orifice translumenal endoscopic surgery.

A relatively new minimally invasive technique, NOTES involves passing an endoscope through a natural orifice and making incisions internally.

Ethicon Endo-Surgery says its studies will focus on up to 40 subjects undergoing either a cholecystectomy or diagnostic peritoneoscopy with surgeons using 1 of 2 different NOTES techniques — transgastric (through the mouth) or transvaginal (through the vagina) — for each procedure. Clinical trials will take place at 4 sites around the country, with each site studying a different type of procedure and method.

Ethicon Endo-Surgery also says it plans to "present the positive preliminary results from 13 studies utilizing devices from the Toolbox" at the SAGES meeting in Phoenix, Ariz., later this week.

—Irene Tsikitas