Assisted Breech to Cephalic Device

  • Category: Medical Devices
  • Investment Status: Advanced
  • Medical Field: Gynecology
  • Patent Status: Provisional
  • Development Status: POC
  • Medical Center: Rabin Medical Center
  • Inventors:  
    Professor Eran Hadar serves as the Head of Unit for Maternal-Fetal Medicine, Women’s Hospital, Beilinson Campus. Rabin Medical Center and serves as a member of the Helsinki Committee. He holds an Academic position at the Sackler Faculty of medicine, Tel Aviv University. Professor Hadar has published dozens of studies in maternal and fetal medicine with an emphasis on pregnancy complications, in collaboration with hospitals, universities and commercial companies in Israel and around the world.

A semi-automated ECV device. The device is comprised of inflatable pillows, positioned in a circular structure around the maternal abdomen.       Each one of these air pillows can be individually and independently inflated by air. This enables the physician to determine the pace at which the fetus is rotated, while exerting controlled (both in force and duration), painless and continuous pressure. The circular array allows for clockwise and counter-clockwise rotation of the fetus.

BACKGROUND About 25% of fetuses will be in breech presentation at 28 weeks, and this decreases to approximately 3-4% in full-term pregnancies. Breech position is defined as a fetus in a longitudinal lie with the buttocks or feet downwards, closest to the cervix. Today, most of the women with a breech presenting fetus will be delivered by cesarean birth, and not by a vaginal breech delivery. Breech presentation ranks as the third most frequent indication for cesarean delivery. It is imperative to assist women to avoid unnecessary cesarean deliveries, and to decrease the overall cesarean delivery rate, which is currently the largest contributing factor to postpartum maternal morbidity.

Current standard of care: Amongst the 3.9 Million births that take place annually in the U.S, it is estimated that around 2-3% will undergo an ECV procedure, with only half being successful. By raising the success rate of ECV procedures we will be able to reduce the need for cesarean operations. The estimated costs for a cesarean delivery are around $25,000 in direct costs, and over $1.5B in total annual expenditure in the U.S alone as a result of failed ECV procedures. This figure does not include the reduction in costs associated with complications resulting from cesarean deliveries, as well as future cesareans in the subsequent deliveries, amounting to billions of dollars in additional costs.