Plexus Biomedical Inc. Gains FDA Approval of the First Medical Device to Help Prevent External Hemorrhoids During Vaginal ... ( OAKLAND Tenn. Feb. 23 2011 /- Plexus ...)

Navigation Links

Biology News Medicine News Biology Products Medicine Products Biology Definition Medicine Definition Biology Technology Medicine Technology Biology Dictionary Medicine Dictionary

HOME >> MEDICINE >> TECHNOLOGY

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

0

GOOD

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:

(Date:5/24/2013)... -- BD (Becton, Dickinson and Company) (NYSE: BDX ), ... will present at the Deutsche Bank 38 th Annual ... a.m. (ET). A live webcast of BD,s ... www.bd.com/investors and will be available for replay through ... BD is a leading global medical technology company that ...

(Date:5/24/2013)... 2013 Solta Medical, Inc. (NASDAQ: SLTM ... reported Dr. Edward W. Knowlton has ... effective immediately. Dr. Knowlton is the founder of Thermage, the ... director since 1996. "On behalf of the entire ... would like to thank Ed for his tireless dedication to ...

(Date:5/24/2013)... , May 24, 2013 Heska Corporation (NASDAQ: HSKA, ... and specialty products, announced today that Dr. Robert ... and Jason Napolitano , executive vice president ... Marcum MicroCap Conference, which is being held May 30, 2013 ... Grand Hyatt Hotel. The Company,s presentation is ...

Breaking Medicine Technology:Dr. Edward W. Knowlton Resigns as a Director of Solta Medical, Inc. 2 Heska Corporation To Present At The Second Annual Marcum LLP MicroCap Conference 2

[0] BD to Present at the Deutsche Bank 38th Annual Health Care Conference [0] Dr. Edward W. Knowlton Resigns as a Director of Solta Medical, Inc.[0] Heska Corporation To Present At The Second Annual Marcum LLP MicroCap Conference

... to a new market research report " ... (ICs, Thermostat, Thermistor, Resistive Temperature Detectors (RTDs), Thermocouple) & ... " published by MarketsandMarkets ( http://www.marketsandmarkets.com ), the ... was $3.27 billion and is expected to reach $4.51 ...

... 29, 2012 Cempra, Inc. (NASDAQ: CEMP ) ... and chief executive officer, will present at the Cowen ... a.m. EST, March 6, 2012, at The Boston Marriott ... overview of the company,s two leading antibiotic clinical programs, ...

Cached Medicine Technology:MarketsandMarkets: Global Temperature Sensors Market Worth $4.51 Billion by 2016 2 MarketsandMarkets: Global Temperature Sensors Market Worth $4.51 Billion by 2016 3 Cempra, Inc. to Present at the Cowen and Company 32nd Annual Health Care Conference 2

MarketsandMarkets: Global Temperature Sensors Market Worth $4.51 Billion by 2016 Cempra, Inc. to Present at the Cowen and Company 32nd Annual Health Care Conference

(Date:5/25/2013)... May 25 (HealthDay News) -- Many viruses and parasites ... and leptospirosis -- a bacteria-borne illness than can result ... at dog parks, according to a veterinarian. ... and even the air, said Dr. Susan Nelson, a ... Center. "Many of these serious diseases can be fatal, ...

(Date:5/25/2013)... May 25, 2013 Providing patients with their ... Doc team of weight management professionals. But, aside from educating ... effectively, Diet Doc’s hCG diets also provide patients, ... during childhood like bullying, more control over their lives by ... dealing with the underlying factors of weight gain derived from ...

(Date:5/25/2013)... New York,NY (PRWEB) May 25, 2013 ... SizeItUp officially declared the integration of the 2012 ... Lamborghini Aventador is the latest entrant in the list ... Designed intelligently, the vehicle is all set to thrill ... with vicious acceleration power and spectacular looks, the 2012 ...

(Date:5/25/2013)... BC (PRWEB) May 25, 2013 According ... the most beautiful and powerful women that ever lived. ... felt by some of the most powerful men in ... many beauty remedies to keep her skin glowing and ... made with bees- wax, maringa oil and cyprus grass. ...

(Date:5/25/2013)... For college students, few events ... they are turning to prescription stimulants like Adderall ... more on this, go to http://www.sciencedaily.com/releases/2013/05/130501145151.htm . ... that students who pick up Adderall, “just to ... developing a physical and psychological dependency. While initially ...

Breaking Medicine News(10 mins):Health News:Hidden Dangers Dog Dog Parks 2 Health News:hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Announces hCG Diet Plans for Those Suffering from Abuse-Related Weight Gain 2 Health News:hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Announces hCG Diet Plans for Those Suffering from Abuse-Related Weight Gain 3 Health News:Rim Fitments Provider SizeItUp Launches The Database Integration For The 2012 Lamborghini Aventador 2 Health News:The Cleopatra Lift - A New Non Surgical Option to Aging Offered by Vancouver Physician 2 Health News:The Cleopatra Lift - A New Non Surgical Option to Aging Offered by Vancouver Physician 3 Health News:Addiction and Drug Abuse: Study Drug Adderall Abuse Spikes During Finals 2

[0] Hidden Dangers Dog Dog Parks [0] hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Announces hCG Diet Plans for Those Suffering from Abuse-Related Weight Gain [0] Rim Fitments Provider SizeItUp Launches The Database Integration For The 2012 Lamborghini Aventador [0] The Cleopatra Lift - A New Non Surgical Option to Aging Offered by Vancouver Physician [0] Addiction and Drug Abuse: Study Drug Adderall Abuse Spikes During Finals

... Director of National Institutes of HealthNEW YORK, Feb. 3 ... the election of Dr. Elias A. Zerhouni , the ... leader in biomedical research, to its Board of Directors."We are ... of Directors," said Dr. Maria C. Freire , President ...

... to Chief Marketing Officer and PACS Industry Veteran ... ManagerWASHINGTON, Feb. 3 Compressus, Inc., leaders in ... team with the promotion of Janine Broda to ... Shawn Gibbons as vice president and general manager ...

... Feb. 3 The Female Health Company (NYSE Alternext: ... conference call to discuss its operating results for the ... (EST) on Tuesday, February 10, 2009. The Company ... the same day. Shareholders and other interested parties may ...

... Go Healthy, Inc. (Pink Sheets: GOHE) announced today that ... for development of major sports relationships at meetings held ... developing partnership with a sports entity, whose members are ... are a major extension of our agreement with Athletic ...

... the best way of spotting trouble, experts say , , ... the stool-based colon cancer tests -- recommended annually for ... to spot potential abnormalities, a German study finds. , ... tests for what is called fecal occult blood -- ...

... ALLEGAN, Mich., Feb. 3 Perrigo Company,(Nasdaq: PRGO ; TASE) today announced results for its fiscal year 2009 second,quarter and six months that ended December 27, ... Perrigo Company, ... Second Quarter Six Months, ... 2009 2008 2009 ...

Lasker Foundation Welcomes Elias Zerhouni to Board of Directors Compressus Bolsters Executive Team to Expand Interoperability Market Pioneered by MEDxConnect(TM)The Female Health Company Schedules First Quarter Conference Call for February 10, 2009 Go Healthy Participates in Super Bowl Events and Developing Sports Relationships Stool-Based Colon Cancer Tests Vary Widely in Accuracy Perrigo Reports Record Second Quarter Sales

Unique supportive clavicle splint. Features front closure design for convenience in application. Comfortable padding over clavicle area....

Indicated for treatment of patella instability...

... and Cronin, Inc. is ... Patient Footwear, Orthopedic Softgoods, ... Products. Our products are ... and available in the ...

... pain relief, stabilization and comfort for patient ... ,The Aspen® "Low Profile" LSO provides immediate ... tightened, using the LeverLatch mechanism, the brace ... of functional mobility and, in many cases, ...

Medicine Products:

Front Closure Clavicle Support 13 Patella Stabilizer w/Cor-Trak Buttress Comfor™ Clavicle Brace - Buckle Closure Aspen® LSO