{"id":163,"date":"2024-08-06T12:34:00","date_gmt":"2024-08-06T19:34:00","guid":{"rendered":"https:\/\/maternamedical.com\/?post_type=press&p=163"},"modified":"2025-03-03T17:17:52","modified_gmt":"2025-03-04T01:17:52","slug":"materna-medical-announces-publication-of-ease-pilot-study","status":"publish","type":"press","link":"https:\/\/www.maternamedical.com\/press\/materna-medical-announces-publication-of-ease-pilot-study\/","title":{"rendered":"Materna Medical Announces Publication of EASE Pilot Study"},"content":{"rendered":"\n

August 6, 2024 Mountain View, Calif.\u2014Materna Medical, Inc., a leading innovator in women’s pelvic health solutions, announces the publication of encouraging clinical results in the article \u201cEffect of an intrapartum pelvic dilator device on levator ani muscle avulsion during primiparous vaginal delivery: A pilot randomized controlled trial\u201d<\/a> in the August Issue of the International Urogynecology Journal.<\/p>\n\n\n\n

The publication reports that the use of a pelvic \ufb02oor dilator (Materna\u2019s Prep Device) reduced pelvic \ufb02oor muscle injury during vaginal delivery in \ufb01rst-time moms. The injury of interest is called a \u201cfull levator ani muscle (LAM) avulsion,\u201d or \u201cLAM injury,\u201d which is when a group of pelvic \ufb02oor muscles fully detaches from the pelvic bone. By effectively preparing the pelvic \ufb02oor muscles to better withstand the strain of childbirth, the Materna Prep Device led to a substantial reduction in LAM injury.<\/p>\n\n\n\n

\u201cThe current standard of care is to allow the pelvic \ufb02oor muscles to stretch suddenly as the baby\u2019s head passes through the birth canal, which leads to a full LAM avulsion about 15% of the time,\u201d said urogynecologist and EASE lead investigator Helai Hesham, MD, Columbia University Irving Medical Center, NY. \u201cBecause these muscles hold the uterus, bladder, and rectum, in place when these muscles are injured, the patient can experience signi\ufb01cant symptoms of sexual, urinary, or fecal dysfunction.\u201d<\/p>\n\n\n\n

Patients were randomized 1:1 to receive either 1) a slow dilation of the pelvic \ufb02oor muscles with the Materna Prep Device over approximately one hour during the \ufb01rst stage of labor or 2) standard care with no intervention.<\/p>\n\n\n\n

Full LAM avulsions were diagnosed by transperineal ultrasound at three months postpartum by an independent panel of expert urogynecologists. A total of 110 \ufb01rst-time moms completed the study and had their ultrasounds reviewed (46 from the Materna Prep Device subject group and 64 from the Standard of Care control subject group). Remarkably, no full LAM avulsions 0.0% occurred in the Materna Prep Device group, while the Standard of Care group experienced a full LAM avulsion rate of 10.9%.<\/p>\n\n\n\n

\u201cRight now, there is no proven way to prevent this injury to the pelvic \ufb02oor. We are hoping that by slowly pre-stretching the pelvic \ufb02oor muscles before the start of pushing the baby out, we can signi\ufb01cantly reduce the injuries that can lead to pelvic organ prolapse,\u201d said maternal-fetal medicine specialist and EASE investigator Dr. Kara Rood. \u201cThe Materna Prep Device is the \ufb01rst device aiming to prevent pelvic muscle injury, so we\u2019re excited to be publishing these results.\u201d<\/p>\n\n\n\n

Based on these pilot study outcomes, the pivotal trial is currently enrolling patients to support a marketing submission to the FDA. Learn more at www.easestudy.org.<\/a><\/p>\n\n\n\n

For more information on Materna Medical, visit MaternaMedical.com<\/a>.<\/p>\n\n\n\n

About Materna Medical<\/strong><\/p>\n\n\n\n

Materna Medical is a novel OBGYN platform company de\ufb01ning a $6B market with core technologies addressing unmet needs in women’s pelvic health. With headquarters in Mountain View, California, Materna pulls from the top minds in MedTech to truly transform the standard of care in OBGYN. With a diverse team of engineers, scientists, researchers, and commercial leaders, Materna Medical\u2019s mission is to empower women to protect their pelvic health.<\/p>\n\n\n\n

Our \ufb01rst product, Milli, is a vaginal dilator to support patients suffering from vaginismus and related painful sex. In 2019, the Milli device was launched as a wellness trainer, and in 2021, it received FDA clearance as a prescription device. In 2023, it received FDA clearance to sell over the counter, enabling streamlined access to people suffering from vaginismus. Milli outcomes are being studied in a post-market prospective virtual study named POMPOM.<\/p>\n\n\n\n

Materna\u2019s second product, Materna Prep, is an investigational device used during labor and is intended to prevent pelvic \ufb02oor muscle injury during vaginal delivery. This product is being studied in the EASE trial<\/a>, a large, randomized, controlled trial in 20 top US hospitals. Materna aims to transform the standard of care in labor and delivery by protecting pelvic \ufb02oor health for moms.<\/p>\n\n\n\n

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Media Contact<\/h2>\n\n\n\n

Debbie Donovan
Head of Commercial Operations Materna Medical, Inc.
Marketing@MaternaMed.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Groundbreaking Pilot Study Provides Preliminary Evidence of Safety and Effectiveness of Innovative Pelvic Floor Dilator in Reducing Childbirth-Related Injuries in First-time Moms<\/p>\n","protected":false},"author":4,"featured_media":144,"template":"","meta":{"_acf_changed":true,"content-type":""},"media-type":[14],"class_list":["post-163","press","type-press","status-publish","has-post-thumbnail","hentry","media-type-press-release"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.maternamedical.com\/wp-json\/wp\/v2\/press\/163","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.maternamedical.com\/wp-json\/wp\/v2\/press"}],"about":[{"href":"https:\/\/www.maternamedical.com\/wp-json\/wp\/v2\/types\/press"}],"author":[{"embeddable":true,"href":"https:\/\/www.maternamedical.com\/wp-json\/wp\/v2\/users\/4"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.maternamedical.com\/wp-json\/wp\/v2\/media\/144"}],"wp:attachment":[{"href":"https:\/\/www.maternamedical.com\/wp-json\/wp\/v2\/media?parent=163"}],"wp:term":[{"taxonomy":"media-type","embeddable":true,"href":"https:\/\/www.maternamedical.com\/wp-json\/wp\/v2\/media-type?post=163"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}