Navigation Links
Pelvalon Announces Results from the LIFE Pivotal Trial at the 2014 AUGS/IUGA Conference
Date:7/23/2014

SUNNYVALE, Calif., July 23, 2014 /PRNewswire/ -- Pelvalon, Inc. is making its clinical debut at the 2014 AUGS/IUGA Scientific Meeting in Washington, D.C. with the presentation of results from LIFE, a pivotal study of the Pelvalon's Vaginal Bowel Control (VBC) System.  Holly E. Richter, Ph.D, M.D., Director of the Division of Urogynecology and Pelvic Reconstructive Surgery at the University of Alabama at Birmingham and immediate Past President of the Society for Gynecological Surgeons (SGS), served as the National Principal Investigator and will be presenting the results at 11:55am on Thursday, July 24, 2014.

The LIFE study followed 61 women who used the VBC system.  At the 1-month primary endpoint, 79% of patients in the intent-to-treat cohort experienced treatment success (86% of patients in the per protocol cohort).  Risks were demonstrated to be very low, with zero device-related serious adverse events observed.  Additionally, 96% of the women who completed the trial found the insert to be comfortable, and 98% said they would recommend it to a friend.  "These results indicate that VBC may allow women to achieve a high degree of continence without risk of significant side effects and with an element of patient control," stated Dr. Richter. "This trial heralds a new era of treatment opportunity for women with bowel control problems."

Pelvalon's VBC System is the first to restore bowel control using a device placed in the vagina.  "Our goal is to provide a front-line therapy that poses minimal risk but delivers superior bowel control," said Pelvalon CEO Miles Rosen. "Today, women frequently don't report their symptoms.  We hope our technology will encourage patients and physicians to start a new dialogue about bowel control."

Over 20 million U.S. women suffer from loss of bowel control, also referred to as Fecal Incontinence (FI) or Accidental Bowel Leakage (ABL).  FI particularly affects women who have experienced pregnancy, childbirth, or nerve or muscle damage in the pelvic region.  Many women suffer in silence, fearing accidents and restricting their daily activities, because of the embarrassing stigma around the condition and the lack of successful, non-invasive treatments. 

About Vaginal Bowel Control
Restoring bowel control through the vagina is a new concept.  The VBC Insert is placed in the same location as a tampon.  The user inflates a balloon on the insert, which is designed to occlude the rectum to protect against unwanted stool passage.  Women can remove the insert at any time.  The VBC System is intended to offer women a non-invasive and non-surgical treatment option. 

The VBC System is limited by federal law to investigational use only and is not available for sale.

About Pelvalon
Headquartered in Sunnyvale, California, privately-held Pelvalon aims to change the lives of women who suffer from bowel control problems. Founded in 2010, Pelvalon's ground-breaking technology originated from Stanford University's Biodesign program, a collaboration between the schools of medicine and engineering.  Pevalon's investors include Norwich Ventures, a specialized venture capital firm focused on medtech.


'/>"/>
SOURCE Pelvalon
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
2. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
3. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
4. Misonix Announces New Distribution Agreement For Panama
5. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
6. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
7. Boston Scientific Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter
8. Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability
9. Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
10. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
11. STAAR Surgical Announces First Quarter 2012 Results Release Date and Conference Call and Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... PUNE, India , June 24, 2016 ... "Pen Needles Market by Type (Standard Pen Needles, Safety ... 12mm), Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase ... published by MarketsandMarkets, This report studies the market for ... is expected to reach USD 2.81 Billion by 2021 ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... - Forecast to 2022" report to their offering. ... for the patients with kidney failure, it replaces the function ... the patient,s blood and thus the treatment helps to keep ... in balance. Increasing number of ESRD patients ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... - Forecast to 2022" report to their offering. ... to date financial data derived from varied research sources to ... potential impact on the market during the next five years, ... of sub markets, regional and country level analysis. The report ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating ... many ways they remain in the eye of the beholder, according to experts who ... of The American Journal of Managed Care. For the full issue, click here ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... that was developed to enhance the health of felines. The formula is all-natural and ... main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from ... at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center ... care topics including advance care planning, healthcare costs and patient and family engagement. ...
(Date:6/25/2016)... ... 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can ... CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn ... X . Simply select a ProHand generator and drag it above media or text ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
Breaking Medicine News(10 mins):