OdonAssist is CE marked and can only be sold in countries that recognize the CE mark. It is not available for sale in other countries and jurisdictions until local regulatory approvals and clearances have been obtained.
A gentle revolution in assisted birth
OdonAssist™ is a new choice, the first truly breakthrough innovation in assisted birth in more than a century.21 Its soft, inflatable design has been shown in clinical studies to be safe3-5 and gentle.4-6
During three clinical trials conducted in the UK and France (2018–2021) 248 women with prolonged or complicated labour gave birth with the assistance of OdonAssist™, with the following beneficial outcomes:
Benefits for babies
Gentle from the start
More than 95% of babies experienced no or low pain from childbirth4,5
No device-specific injuries
No device-related typical pattern of injury4-5, unlike forceps or vacuum extraction, which may cause complications such as bruising, cephalohematoma, and caput succedaneum (head elongation)
Benefits for mothers
Safe by design
No serious maternal adverse reactions related to the device3-5
More comfortable
All mothers reported a positive experience with OdonAssist4
Benefits for practitioners
Designed for ease of use
Unlike forceps and vacuum, with OdonAssist™ the same insertion technique is used for all cephalic vertex (fetal head) positions3-5
Proven effectiveness
OdonAssist™ achieved a successful delivery rate of up to 88.5%5
Median time from application to birth was less than 8 minutes3,5
Benefits for care facilities
Better outcomes
By potentially reducing the need for medically unnecessary C-sections, OdonAssist™ may reduce costs and deliver better outcomes for mothers and newborns.
Patient preference
Women wish for a kinder AVB, an alternative to forceps and ventouse6
Gentle by design
With just two main parts, the OdonAssist™ is gentle4-6, safe and easy to use.3-5
1
Applicator
Guides the soft sleeve safely and easily
Same insertion technique for all cephalic vertex presentations3-5
Soft air cuff provides gentle contact while assisting birth
Pressure limiter ensures air cuff inflation is safe
Sleeve handles enable doctor to assist delivery
Hover to learn the features
“It can be used in all fetal head positions. Less traumatic. Easier to use.25”
It’s official
OdonAssist™ is now CE Marked and has been approved for use in clinical settings in Europe based on the results of trials funded by the Bill and Melinda Gates Foundation at maternity hospitals.
1
In a clinical trial, women and midwives articulated views suggesting the common belief that forceps are more ‘traumatic’ either physically or emotionally.6
2
In a clinical trial, midwives perceived that the OdonAssist™ is kinder than other devices and described the births as ‘softer’, ‘nicer’, ‘beautiful’, ‘easy’, ‘smooth’ and ‘gentle’.6
3
In all clinical trials OdonAssist™ was demonstrated to be safe for the baby3-5, with no typical pattern of the neonatal bruising or injury that can result from the use of other assisted vaginal birth devices.4,5
4
The efficacy (successful assisted birth) rate with OdonAssist™ in clinical trials was up to 88.5%.5
5
If OdonAssist™ does not deliver the newborn it can be removed easily, allowing for other interventions.4-5
6
Unlike forceps and vacuum extraction, with OdonAssist™ the insertion technique is the same for all fetal head positions in cephalic presentations.3-5
Published research & press
Data, evidence and expert opinion about the OdonAssistTM device have been published in more than 20 medical publications. View the most current here.
The Odon Device™ inflatable device for assisted vaginal birth – the ASSIST II study (UK).
Safety and efficacy of the OdonAssist™ inflatable device for assisted vaginal birth: the Besancon ASSIST study.
Women's experiences of the Odon Device to assist vaginal birth and participation in intrapartum research: a qualitative study in a maternity unit in the Southwest of England.
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