OAKLAND, Tennessee, June 28, 2012 /PRNewswire/ -- An observation by Dr. Daniel Burns, Chief of Obstetrics at Niagara Falls Memorial Hospital has prompted the physician to initiate a prospective clinical trial to determine whether the Hem-Avert® Perianal Stabilizer can reduce the incidence of Cesarean sections (C-sections) among women.
The Hem-Avert Perianal Stabilizer is a disposable device that applies pressure to perianal tissue during childbirth. The noninvasive, patented device is approved by the US Food and Drug Administration (FDA) to help prevent the occurrence of external hemorrhoids during vaginal childbirth.
However, during the course of using the Hem-Avert device to treat his patients, Dr. Burns began to observe an interesting trend. According to Dr. Burns, "... the Hem-Avert is a tool our facility uses to provide better patient outcomes. I personally noticed a reduction in C-section rates at our hospital with use of the device. The Hem-Avert helps women who have undergone an epidural push more effectively. Our hospital is currently running a prospective study looking at reduced C-sections rates with use of the Hem-Avert device."
Upon learning of Dr. Burn's experience, Plexus Biomedical, Inc., the device manufacturer, conducted a retrospective analysis of the original study data presented to the FDA to support its initial application. This analysis indicated a 15.1% overall reduction rate in C-sections among patients who received the Hem-Avert device compared to those who delivered without the device. Biostatisticians were also able to determine an NNT of seven (7) associated with the device, which means that one Cesarean birth was prevented with every seven devices used.
Dr. Burns is currently recruiting 200 patients to participate in a prospective, randomized study to assess C-section rates with and without the device. Results from the study are expected to be released later this year.
Reducing the necessity for C-sections is important to patients as C-sections themselves are invasive procedures which may result in more costly and longer: hospitalizations, complications, and recovery.
CEO David Blurton stated, "The potential cost savings for payors and hospitals are enormous. A study by Intermountain Healthcare suggests unnecessary C-sections are a billion dollar problem."
The company expects to receive their CE registration for the Hem-Avert device shortly and is currently working on expanding its international distribution. The device is already available in the United States and the Middle East.
Indication for Use: The Hem-Avert® Perianal Stabilizer is designed to provide counter-pressure to the anus during vaginal childbirth. This counter-pressure force helps prevent the occurrence of external hemorrhoids during vaginal childbirth. This instrument is for external use only.
Not for release or distribution in the U.S.A.
 This analysis reflects preliminary data and Plexus Biomedical makes no claims on reduced C-section rates based on these findings.
 Johnson N. Unnecessary C-sections a $3.5B problem, study finds. California Watch. January 19, 2011. Found at: http://californiawatch.org/dailyreport/unnecessary-c-sections-35b-problem-study-finds-8133
SOURCE Plexus Biomedical, Inc.