Assisted vaginal birth with the Odon DeviceTM.

The Odon DeviceTM is an innovative investigational device for assisted vaginal birth (AVB) and has not yet been granted regulatory approval for sale in any country. It is the first innovation in AVB since the introduction of the vacuum extractor in the 1950's and the device is designed for use by different level of trained health care providers. Efficacy studies are presently in progress in two centers: The ASSIST II Study, Bristol, England, and The BESANCON ASSIST Study, Besançon, France. The device consists of an applicator, sleeve and cuff. This original paper illustrates the operating process in real conditions.