Navigation Links
Plexus Biomedical Inc. Gains FDA Approval of the First Medical Device to Help Prevent External Hemorrhoids During Vaginal Childbirth
Date:2/23/2011

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 www.hem-avert.com or contact Plexus Biomedical, Inc.

David Blurton

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

info@plexusbiomedical.com



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:
*Name:
*Comment:
*Email:
(Date:6/12/2017)... 12, 2017 Kineta, Inc., a biotechnology company focused ... Vice President of R&D and Head of Virology Kristin ... Preparedness for the Northwest and Beyond meeting sponsored by ... 14, 2017 from 8:30-10:30 AM PDT at the Agora Conference ... Dr. Bedard will be joined by other leaders in ...
(Date:6/9/2017)... PALO ALTO, Calif. , June 9, 2017 /PRNewswire/ ... medical device company focused on the design, manufacture, sale ... updated the market on the progress of its commercial ... AeroForm is now available in more than one hundred ... country. AeroForm offers a needle-free alternative ...
(Date:6/8/2017)... Responding to Heath Ledger,s father,s recent call for ... Chris Cornell in May, the mental health watchdog group, ... psychiatric drug side effects search engine ... risks. The father of the late actor ... has called for tighter rules on prescription drugs. Speaking at ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... June 23, 2017 , ... Dr. ... New York, has recently begun offering three new minimally invasive procedures to patients ... procedures and reducing downtime, Dr. Rubinstein is excited to bring microneedling, microneedling facials, ...
(Date:6/23/2017)... ... June 23, 2017 , ... Ensuring meat ... new videos highlight the importance of correctly using a meat thermometer. The videos ... done extensive research on consumer food safety habits. Dr. Bruhn explains the variety ...
(Date:6/23/2017)... ... June 23, 2017 , ... Ross Insurance Agency ... the Federal Emergency Management Agency’s (FEMA) recent update of flood zones, more people ... the Biggert-Waters Act was enacted to reflect the actual risk in flood zone ...
(Date:6/23/2017)... ... June 23, 2017 , ... All-Star Insurance, a family managed agency that offers ... Texas, is announcing the launch of a new charity drive to benefit women in ... United States reveal that an estimated 252, 710 new cases of invasive or high ...
(Date:6/22/2017)... ... June 22, 2017 , ... United Benefit Advisors ... Whipple & Company as its newest Partner Firm. Headquartered in Coconut Creek, Florida, ... risk while tailoring optimized benefit packages that strengthen the relationship between employer and ...
Breaking Medicine News(10 mins):