The National Institute for Health and Care Excellence Recommends Fetal Pillow® As Standard Arrangements

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• USA - English

Updated Guidance Reflects Real World Impact of Technology

TRUMBULL, Conn., Jan. 19, 2023 /PRNewswire/ -- CooperSurgical, a global leader in fertility and women's health, today shared that the National Institute for Health and Care Excellence (NICE) recommended Fetal Pillow to be used under standard arrangements during delivery if a baby's head becomes stuck in the pelvis. NICE provides national guidance and advice to improve health and social care in the United Kingdom by putting science and evidence at the heart of healthcare decision making. NICE is an executive non-departmental public body, sponsored by the Department of Health and Social Care.

"NICE's evidence-based guidance recognizes that there is sufficient data for the safe and effective use of Fetal Pillow. This recommendation will aid clinicians in emergent situations during the second stage of labor that require a cesarean section," said Dr. Vrunda Desai, VP of Medical Affairs, CooperSurgical. "We have seen meaningful results from the use of Fetal Pillow, including on average, a one-day reduction in length of hospital stays for the patient, as well as a 20-minute reduction in operating time for the physician."¹ When asked, 97% of U.S. physicians in the study* responded that they would recommend the use of Fetal Pillow to others.²

Fetal Pillow is a balloon cephalic elevation device for use in cesarean sections performed during the second stage of labor (over 37 weeks). It was created to elevate the fetal head and facilitate delivery of the fetus in women requiring a cesarean at full dilation, or those requiring a cesarean after a failed instrumental vaginal delivery.³ Fetal Pillow is inserted during patient preparation for a cesarean section and inflated with saline to elevate the fetal head.⁴ The device allows for a significant shift from the expected difficulty in delivering the fetal head to an actual ease of delivery.¹

"NICE's evidence-based recommendation will help drive more widespread use of Fetal Pillow, a device that has been shown to reduce both maternal and fetal morbidity,"^1,5 stated Holly Sheffield, President, CooperSurgical. "Our work to showcase the real-world results with Fetal Pillow over the last decade, will now help to elevate the standard of care for mothers and babies across the United Kingdom. This is a true testament to CooperSurgical's commitment to a world with healthy women, babies, and families."

To learn more about CooperSurgical, please visit https://coopersurgical.com/

Fetal Pillow is indicated to elevate the fetal head and facilitate delivery of the fetus in women >37 weeks gestation undergoing cesarean section at full dilation (with or without an instrumental delivery). The Fetal Pillow is contraindicated in the presence of an active genital infection. The safety and effectiveness of Fetal Pillow has not been established in the following: previous cesarean section, <37 weeks gestation, non-vertex presentation, intrauterine fetal death, pregnancy induced hypertension, intrauterine growth retardation, diabetes, major congenital abnormalities, chorioamnionitis, and multiple gestations. For detailed benefit and risk information, please consult Instructions for Use. http://www.fetalpillow.com/instructions-for-use

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (NYSE: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's healthcare clinicians. More information can be found at https://www.coopersurgical.com/.

CooperCompanies ("Cooper") is a global medical device company publicly traded on the NYSE (NYSE:COO). Cooper operates through two business units, CooperVision and CooperSurgical. CooperVision brings a refreshing perspective on vision care with a commitment to developing a wide range of high-quality products for contact lens wearers and providing focused practitioner support. CooperSurgical is committed to advancing the health of women, babies, and families with its diversified portfolio of products and services focusing on medical devices and fertility & genomics. Headquartered in San Ramon, CA, Cooper has a workforce of more than 14,000 with products sold in over 100 countries. For more information, please visit www.coopercos.com.

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*n=51

¹ Seal SL, Dey A, Barman SC, Kamilya G, Mukherji J, Onwude JL. Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilatation. Int J Gynaecol Obstet. 2016;133(2):178-182.
² Lassey SC, Little SE, Saadeh M, et al. Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020;135(4):879-884.
³ FDA Approval Letter - July 27, 2017
⁴ Fetal Pillow – Instructions for Use
⁵ Seal, S.L., Dey, A., Barman, S.C., Kamilya, G., Mukherji J. Does elevating the fetal head prior to delivery using a fetal pillow reduce maternal and fetal complications in a full dilatation caesarean section? A prospective study with historical controls. J Obstet Gynaecol. 2014;34(3):241-244.

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