Navigation Links
Plexus Biomedical Inc. Gains FDA Approval of the First Medical Device to Help Prevent External Hemorrhoids During Vaginal Childbirth

OAKLAND, Tenn., Feb. 23, 2011 /PRNewswire/ -- Plexus Biomedical Inc. has been granted a new classification and approval from the Food and Drug Administration to market the first device clinically shown to help prevent external hemorrhoids during vaginal childbirth. Hemorrhoids associated with vaginal delivery are a frequent complication of childbirth and affect between 750,000 and 1,000,000 pregnant women in the U.S. every year.

The patented Hem-Avert® Perianal Stabilizer supports the perianal region of the patient during labor and delivery.  The unique device is easily applied, completely external and will soon be available to physicians and hospitals nationwide.

CEO David Blurton stated, "Since there were not any competitive products or predicate devices that addressed delivery-induced hemorrhoids, the company conducted a prospective, randomized, multicenter clinical study to provide the clinical data necessary for the FDA to create a new classification for the device through its de novo 510(k) process."

Findings from the clinical study showed that none of the women randomly chosen to use the Hem-Avert® device during labor and delivery developed hemorrhoids.  By contrast, 25% of the women in the control group who delivered without the Hem-Avert® device developed hemorrhoids as a direct result of vaginal delivery, a finding consistent with the reported incidence of hemorrhoids documented in medical literature.

The high incidence of delivery-induced hemorrhoids among all vaginal births yields a potential U.S. market in excess of $650M.  When combined with vaginal births from Canada and Europe, the potential market for the Hem-Avert® device doubles to $1.3B. The company believes better patient outcomes, cost savings, and patient demand will all contribute to the product's success.

Plexus Biomedical is dedicated to revolutionizing obstetrics by eliminating or reducing common problems and morbidities associated with childbirth.  The company already has two issued United States Patents covering the Hem-Avert® Perianal Stabilizer with additional patent applications pending in the United States and internationally.

For additional information visit or contact Plexus Biomedical, Inc.

David Blurton

(901) 763-2900 or (877) 844-4767

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.

©2011 Plexus Biomedical, Inc. All rights reserved. Hem-Avert® is a registered trademark of Plexus Biomedical, Inc.

SOURCE Plexus Biomedical Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Dr. Paul Janssen Award for Biomedical Research Issues Call for Nominations
2. BioMedical Enterprises, Inc. (BME) Introduces the HammerLock™ Shape Memory Device for Hammertoes.
3. Synapse Biomedical Receives FDA Humanitarian Use Device Designation for Amyotrophic Lateral Sclerosis (ALS)
4. DSM Biomedical to be Key Contributor at the Surfaces in Biomaterials Foundations 2010 BioInterface Symposium and Workshop
5. DuPont and DSM Announce Joint Venture in Surgical Biomedical Materials
6. ETC Biomedical Systems Offers New FDA Approved Hyperbaric Oxygen Therapy (HBOT) Medical Device
7. BINDER BIOMEDICAL, INC. Announces Official Launch of the NEWTON™ Intervertebral Body Fusion Spinal Spacer System
8. Crux Biomedical Named One of Top 50 Companies to Watch
9. Crux Biomedical Enrolls First Patient in Its Retrieve 2 U.S. Pivotal Trial
10. Drexel Biomedical Researchers Develop Device to Predict Diabetic Wound Healing
11. West Haven Firm Expands Biomedical Disposal Program with Community Economic Development Fund
Post Your Comments:
(Date:12/1/2015)... VANCOUVER , Dec. 1, 2015  Following an ... (NASDAQ: OGXI ) announced today that its Phase ... interim futility analysis of the intent-to-treat (ITT) population. In ... identified by the DMC. Both the DMC and OncoGenex ... expected in the second half of 2016, depending on ...
(Date:12/1/2015)... , Dec. 1, 2015 WellStar Health ... Dallas, Texas -based Tenet Healthcare,s five metro ... of Trustees approved the strategic move following the conclusion ... its proven clinical care models and patient safety programs ... to healthcare to new communities. --> ...
(Date:12/1/2015)... , Dec. 1, 2015   Nottingham Spirk ... today announced the publication of a free ... Direct-to-Consumer Medical Market". The whitepaper gives medical product ... successfully penetrating this lucrative segment. Nottingham ... products to manage their own health, save money ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... The Multiple System Atrophy Coalition has announced the ... System Atrophy (MSA) research, timed today to coincide with Giving Tuesday 2015, a global ... their ability to work and be productive, to do simple daily activities like walking ...
(Date:12/1/2015)... , ... December 01, 2015 , ... ... in rural West Tennessee to receive Gigabit Internet through a partnership this year ... America’s largest cities, Henderson is an attractive destination for entrepreneurs who want to ...
(Date:12/1/2015)... ... December 01, 2015 , ... Integrated Rental Services (“Integrated ... Industries International, LLC (“JII”). , With support from JII, Integrated Rental is poised ... hospitals, surgery centers, clinics, research labs and medical facilities across the United States. ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... and hematology continuing medical education (CME), today announced that the first annual School ... New York. , “The prevention, detection and treatment of gastrointestinal cancers are undergoing ...
(Date:12/1/2015)... ... December 01, 2015 , ... Dr. Paul Vitenas, one of the ... been named by MedEsthetics magazine as the Best Single Physician Practice in the nation. ... many elite aesthetic physicians honored by the industry publication. , Dr. Vitenas said ...
Breaking Medicine News(10 mins):