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
'/>"/>

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

Page: 1 2

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:7/30/2015)... , July 30, 2015  Unichem Pharmaceuticals ( ... one lot of Hydrochlorothiazide tablets 25 mg 1000-count bottle ... as a precautionary measure due to the identification of ... product. The risk associated with mistakenly ... is the increased probability of experiencing Clopidogrel,s side effects ...
(Date:7/30/2015)... 30, 2015  Amgen (NASDAQ: AMGN ) today announced ... director of Warburg Pincus LLC, to the Amgen Board of ... Fred Hassan and the deep, global experience he brings ... Robert A. Bradway , chairman and chief executive officer of Amgen. ... serve Amgen well." Mr. Hassan has been Partner ...
(Date:7/30/2015)... July 30, 2015  Growth of the U.S. nonprescription ... bring former prescription users to the OTC market. Due ... forecasts robust Rx-to-OTC switch activity over the next five ... with many new brands entering the market into existing ... next five years (even those with low to moderate ...
Breaking Medicine Technology:Unichem Pharmaceuticals (USA), Inc. Issues a Voluntary Nationwide Recall of Hydrochlorothiazide Tablets Due to the Potential Presence of Foreign Tablets 2Amgen Announces Appointment Of Fred Hassan To Board Of Directors 2Amgen Announces Appointment Of Fred Hassan To Board Of Directors 3Rx-to-OTC Switches -- Game Changers for the U.S. OTC Drugs Market through 2019, Sees Kline 2Rx-to-OTC Switches -- Game Changers for the U.S. OTC Drugs Market through 2019, Sees Kline 3
(Date:7/30/2015)... FL (PRWEB) , ... July 30, 2015 , ... ... Florida’s (UCF) College of Medicine as Assistant Professor of Plastic Surgery. This is ... Dr. Clevens has worked closely with the university, developing a strong presence and a ...
(Date:7/30/2015)... ... July 30, 2015 , ... ... the latest issue of Inclusive™ magazine, its multimedia publication focused on implant dentistry, ... of the new issue, Volume 6, Issue 2, as well as past issues ...
(Date:7/30/2015)... ... July 30, 2015 , ... Boston Web Marketing ... Summit. Google Partners is the platform for search marketing agencies to communicate with ... tools necessary to run successful search marketing campaigns. Google Partners also affords businesses ...
(Date:7/30/2015)... ... July 30, 2015 , ... Quintessa Medical Spa is happy ... nonsurgical treatment designed specifically for the elimination of excess tissue under the ... locations in the state of Wisconsin to offer this innovative treatment. , Developed by ...
(Date:7/30/2015)... ... 30, 2015 , ... The American Association of Poison Control ... the reinstitution of National Prescription Drug Take-Back Days. The 10th event of this ... 2:00 PM local time. On the 26th, the DEA, with the assistance of ...
Breaking Medicine News(10 mins):Health News:Leading Melbourne Facial Plastic Surgeon Reappointed by UCF 2Health News:Leading Melbourne Facial Plastic Surgeon Reappointed by UCF 3Health News:Glidewell Laboratories Puts Out Latest Issue of Dental Implant Magazine Inclusive™ 2Health News:Glidewell Laboratories Puts Out Latest Issue of Dental Implant Magazine Inclusive™ 3Health News:Glidewell Laboratories Puts Out Latest Issue of Dental Implant Magazine Inclusive™ 4Health News:Boston Web Marketing Attends Google Partners All-Stars Summit 2Health News:Quintessa MedSpa Offers Nonsurgical Double-chin Elimination 2Health News:AAPCC Supports National Prescription Drug Take-Back Day 2Health News:AAPCC Supports National Prescription Drug Take-Back Day 3
... ... them , ... 2010 -- Still hunting for the perfect Mother,s Day gift idea? While it,s wonderful to ... universally don,t have enough of is sleep. With Mother,s Day right around the corner on May ...
... ... Assess & Treat the Country’s Pest Management Needs, , ... (PRWEB) April 29, 2010 -- Most people are aware of the ... January 12th. While the country is still dealing with widespread damage to its infrastructure ...
... Geneva, 29 April 2010 -- Lung cancer patients whose tumors ... than those who do not, Canadian researchers have found. Their ... Geneva, highlights the exciting possibility that the molecule could soon ... is a receptor that is found on the surface of ...
... Practicing non-pharmaceutical interventions (NPIs) such as hand-washing and ... pandemic flu, but more research on these measures is ... May issue of AJIC : American Journal ... Association for Professionals in Infection Control and Epidemiology, Inc. ...
... ... errors and boost quality of service , ... Trevose, PA (PRWEB) April 29, 2010 -- Airclic, ... logistics and field service operations, today introduced Clinical Perform, a SaaS-based mobile software product ...
... clumps of protein, not plaques, may cause the disease, ... research could change the way scientists view the causes -- ... A study published online this month in the Annals ... (abeta) proteins called oligomers could be a prime cause of ...
Cached Medicine News:Health News:The Perfect Mother's Day Gift Idea: A Good Night's Sleep 2Health News:Clark Pest Control Executive Asked to Aid Haitian Government with Post-Earthquake Pest Issue 2Health News:Clark Pest Control Executive Asked to Aid Haitian Government with Post-Earthquake Pest Issue 3Health News:CXCR4: A new drug target in lung cancer 2Health News:Hand-washing, mask-wearing may limit transmission of pandemic flu 2Health News:Hand-washing, mask-wearing may limit transmission of pandemic flu 3Health News:Airclic Introduces Clinical Perform™ 2Health News:Airclic Introduces Clinical Perform™ 3Health News:New Finding Could Mark Shift in Alzheimer's Research 2Health News:New Finding Could Mark Shift in Alzheimer's Research 3
... No need to add individual components ... range of trauma indications. Made of an ... than conventional fixators, only much lighter. This ... apply, and more comfortable for the patient. ...
... an X-ray contrast medium for ... for: angiography, urography, phlebography and ... of the basal cisterns, following ... cholangio (pancreato) graphy (ERC(P)), herniography, ...
... (gadobenate dimeglumine) is a paramagnetic MRI contrast ... with gadobenate, a chelating agent that forms ... godolinium ion. It is salified with meglumine ... with all the physico-chemical features typical of ...
... ferumoxides) is Advanced Magnetics' contrast agent for use ... It is the first organ-specific MRI contrast agent ... function, the agent is taken up by macrophages ... in most tumors. The liver is a principal ...
Medicine Products: