Fetalease Granted Investigational Device Exemption (IDE) Approval For Its Yaari Extractor For Shoulder Dystocia Births

(MENAFN- EIN Presswire)

Shoulder dystocia. The Yaari Extractor is the only device-based solution for what is considered by many OBGYNs to be 'the obstetrician's nightmare'.

Company to initiate a US clinical study for the only device for treating the obstetric emergency that can lead to fetal and maternal injury and fetal death.

HAIFA, ISRAEL, May 9, 2023/einpresswire.com / -- The U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) approval for a clinical study of the yaari extractortm in the treatment of emergency shoulder dystocia births.

Shoulder dystocia is a rare but feared obstetric emergency in which the baby's head has been born but one of the shoulders becomes stuck behind the mother's pubic bone, delaying the birth of the baby's body. The dystocia must be dealt with within 5-7 minutes to prevent serious injury or death to the baby and is currently managed by a series of manual maneuvers which are intended to release the baby's shoulder. Shoulder dystocia and the use of manual maneuvers can result in maternal injury as well as injury, permanent disability, and death to the baby, with the most common injury being brachial plexus injury (BPI).

The Yaari Extractor, developed by FetalEase, is a simple mechanical device that is intended to resolve shoulder dystocia by removing the impacted anterior fetal shoulder from behind the maternal pubic bone and moving it to a position where it can be delivered. Using the device, the physician can maneuver the fetus and enable delivery without applying traction to the fetal head or brachial plexus. It is currently the only device-based solution for this serious obstetric situation. The Yaari Extractor has been successfully used in initial clinical cases as part of a First-in-Woman study at the Suyog Women's Hospital in Mumbai.

FDA's IDE approval allows the Yaari Extractor to be used in a pivotal clinical study to evaluate safety and effectiveness of this device for its intended use. The data generated from this IDE clinical study will be used to support a marketing application to the FDA.

“Shoulder dystocia is considered 'the obstetrician's nightmare' by many OBGYNs. We are pleased to have received FDA's approval to initiate our study and have assembled a stellar team to conduct this study under the leadership of our principal investigator, Dr. Robert Gherman, a leading researcher in the field of shoulder dystocia”, stated Aaron Feldman, FetalEase's CEO. The company, which is currently setting up its clinical sites and raising an investment round, expects to initiate the study during Q3 2023.


About FetalEase:

FetalEase Ltd. is a privately held Israeli start-up company founded in 2016 to develop the Yaari Extractor and to commercialize it worldwide. The device was invented by Dr. Abraham Yaari, an OBGYN with over 20 years of experience delivering babies in the U.S. and Israel.
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SOURCE FetalEase Ltd.

Aaron Feldman
FetalEase Ltd.

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