NORTH ANDOVER, Mass.--(BUSINESS WIRE)--MindChild Medical, Inc., today announced results of a recently sponsored national survey of hospital administrators and obstetricians (NSFM3) focused on trends in fetal monitoring. Recent fetal monitoring literature suggests that of the 4.3 million US live births recorded in 20074, 1.4 million, or over 30%5, occurred where the mother had a BMI (Body Mass Index) exceeding 30kg/m2 considered the effective limit for existing non-invasive fetal monitoring technology6.
Key findings of the NSFM Survey included:
- Respondents employ a fetal heart (FHR) monitor in 99.2% of deliveries
- Over 75% of deliveries utilize some form of non-invasive FHR monitoring
- Invasive FHR monitoring occurs in approximately 25% of all labor episodes
- Respondents reported that in over 20% of deliveries, an unreliable non-invasive FHR tracing leads to use of a Fetal Scalp Electrode (FSE) to monitor the fetus’s heart rate
- The vast majority of respondents reported an observed increase in BMI for admitted delivering mothers over the past 5 years
- Respondents reported that nearly 40% of deliveries are to mothers with a BMI greater than 30kg/m2
- Respondents noted that nearly 30% of delivering mothers are at, or above, a BMI that they feel adversely affects accurate FHR monitoring
Michael G. Ross, MD, MPH7, Professor, Department of Obstetrics and Gynecology at the Geffen School of Medicine at UCLA commented, “Noninvasive FHR monitoring may result in inadvertent monitoring of maternal heart rate, which can be mistaken for fetal heart rate, particularly in obese patients. The increase in maternal BMI seen nationally over the recent past is a troubling trend that has significant negative implications for the accuracy of existing non-invasive FHR monitoring technologies. The use of non-invasive surface electrodes can potentially improve in the monitoring of fetal heart rate and aid in prevention of adverse outcomes associated with mistaken maternal heart rate monitoring.”
Previous Announcements
On February 22, 2012, MindChild reported formation of a Clinical Advisory Board for the MERIDIAN™ Line of Non-Invasive Fetal Heart Rate Monitors
On February 6, 2012, MindChild reported filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the MERIDIAN™ Line of Non-Invasive Fetal Heart Rate Monitors
About the MERIDIAN Non-Invasive Fetal Heart Rate Monitor
MERIDIAN is a fetal monitor that non-invasively measures and displays Fetal Heart Rate (FHR). MERIDIAN acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). MERIDIAN may also be used to measure and display FHR using a Fetal Scalp Electrode (FSE). MERIDIAN is designed for women who are at term (> 36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. MERIDIAN is intended for use by healthcare professionals in a clinical setting.
About the Fetal Heart Monitoring Market
Over 85%8 of the 4 million9 live births occurring in the US during 2011 required fetal monitoring during labor and delivery. Current non-invasive Doppler ultrasound, employed to detect fetal heart rate is subject to gaps in fetal monitoring due to fetal/maternal movement10. Fetal scalp electrodes that connect directly to the fetus during the later stages of labor and delivery are associated with increased risk of fetal/maternal infection11. There are an estimated 28,000 fetal monitors spread over 3,400 hospitals in the US12, representing an investment of over $700,000,00013. MERIDIAN has been developed to provide uninterruptible non-invasive fetal heart rate monitoring while addressing the reported deficiencies associated with Doppler and fetal scalp electrodes.
About MindChild Medical, Inc.
MindChild Medical, Inc., is a privately funded medical device company founded in 2008. MindChild’s principal technology platform, the MERIDIAN non-invasive fetal electrocardiograph monitor, is designed to report fetal heart rate data equivalent to the gold standard fetal scalp electrode in addition to novel ECG metrics intended to provide obstetricians a deeper understanding of fetal/maternal health and management.
MindChild was co-founded by Adam Wolfberg, MD, Assistant Professor, Tufts Medical Center, Gari Clifford, PhD, previously Principal Research Scientist at Harvard-MIT Division of Health and Science Technology (currently on the faculty at the University of Oxford in the Department of Engineering Science), James Robertson, President and CEO, and Jay Ward, Executive Vice President, both of E-TROLZ, Inc. MindChild has exclusively licensed intellectual property from the Massachusetts Institute of Technology, Tufts Medical Center and E-TROLZ, Inc., a Massachusetts technology company that develops and commercializes breakthrough physiologic monitoring platforms for a wide variety of applications.
For more information, please visit www.mindchild.com.
1 Meridian Fetal Monitor is not available in the United
States. Pending 510(k) clearance.
2 Company data on file
3
Full NSFM Survey results on file at MindChild Medical, Inc.
4
Derived from Live Births, Deaths, Marriages, and Divorces: 1960 to 2007
Source: U.S. National Center for Health Statistics, Vital Statistics of
the United States, and National Vital Statistics Reports, (NVSR); <http://www.cdc.gov/nchs/nvss.htm>.
5
A. Branum, CDC, Hyattsville, Maryland, December 2, 2008
6
Company data on file - April 2012 fetal monitoring nursing staff survey
interviews regarding Doppler FHR limits vs. maternal BMI
7
Michael G. Ross, MD, MPH is a member of the Clinical Advisory Board for
MindChild Medical, Inc.
8 "ACOG Refines Fetal Heart Rate
Monitoring Guidelines", 6/22/2009 The American College of Obstetricians
and Gynecologists Press Release
9 http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_03.pdf
10
Journal of Midwifery. Vol 18, No, 7: 424-428. July 2010
11
American Family Physician, 1992 Feb;45(2):579-82
12 http://www.aha.org/aha/resource-center/Statistics-and-Studies/fast-facts.html
13
Company estimates.