Navigation Links
Distribution of C SAFE medical device for safer cesarean sections by preventing lacerations to newborns expands domestically and internationally

IRVINE, Calif., June 28, 2012 /PRNewswire/ -- Brolex announced today that the C SAFE cesarean section safety device is now in distribution channels across the United States and Internationally. These channels are providing hospitals in 10 states and 7 countries access to the C SAFE medical device. Over 60 US hospitals have now received these first supplies of C SAFE for their Labor & Delivery Departments.


Brolex LLC is the owner and manufacturer of the C SAFE medical device. C SAFE is a novel medical device clinically tested and designed specifically for performing safer cesarean sections by preventing lacerations to newborns.

Four million (4.0M) babies are born in the US annually. Five and a half million (5.5M) in EU countries total. Cesarean sections are performed in two primary patient populations; 1) emergent situations, and 2) scheduled elective cesarean sections. In the US, cesarean sections account for 25 - 38% of babies born. European rates are higher nearing 44% of births. In Mexico, a 38% rate in the general population, and a 50% rate in wealthier populations. Chile has a 40% c/section rate. China is home to the greatest number of births, 16.4 million annually, with one of the greatest c/section rates of nearly 50%.

Published literature documents there is a 1.5 - 3.0% risk of lacerations or nicks in these c/sections.  There is strong evidence to suggest that this rate is actually higher than reported or documented. At a documented risk of 1.5 - 3.0%, this translates to up to 45,000 newborns annually that experience some level of laceration injury related to the c/section surgical procedure. For nonvertex cesarean sections, reports of a 6.0% risk for lacerations nearly double the number of injuries to newborns.

The C SAFE medical device reduces or eliminates laceration injury risks. Benefits of using C SAFE, as well as implementing a Risk Management and Patient Safety Initiative Program using the C SAFE device include:

  • Clinical outcomes improvement for newborns
    • Eliminate minor lacerations to acute injuries
      • Avoid short term to long term complications
  • Minimize / eliminate medical intervention costs on laceration injuries
  • Proactively address medicolegal implications
    • Lacerations do occur,
      • and have negative medical and economic consequences
    • Implications of "Best Medical Practices"
      • What if the safer device is not used, and an injury occurs
  • Risk mitigation programs
    • Clinical Risk Mitigation
    • Legal Risk Mitigation
    • Economic Risk Mitigation

About Brolex LLC
Brolex LLC owns the C SAFE trademark and patents worldwide. C SAFE is FDA cleared as a general surgical device. Brolex completed a 40 patient clinical trial in the US. Followed by a device registry trial now having distributed 500 devices for c/section deliveries. For more information, visit

Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Industry Veteran Brings Sales Expertise to AlloSources Growing Distribution Network
2. Misonix Announces New Distribution Agreement For Panama
3. Fuse Science Partners With GNC To Open National Distribution Of EnerJel™
4. Lilly Applauds Law Enforcement Officials for their Successful Investigation and Recovery of Pharmaceuticals Stolen from Connecticut Distribution Center
5. Coping With New FDA Mandates For Drug Sample Distribution
6. Debiopharm and Vifor Pharma Sign an Exclusive Agreement for the Distribution and Commercialization of Pamorelin®LA in Switzerland - A Drug Treatment for Prostate Cancer and Endometriosis
7. EnerJel™ Adds 200 Independent Pharmacies To Distribution Base
8. Cephasonics Inks Distribution Deal With Tritech To Extend Worldwide Sales Reach Into Israel
9. PolyOne Announces Expansion in Costa Rica with Healthcare-Focused Distribution Services
10. Cariflex™ Polyisoprene Products by Kraton Performance Polymers Added to PolyOne Distribution Product Line
11. Ted Pacha Joins Pinnaclife as President of its Healthcare Distribution Division
Post Your Comments:
(Date:11/24/2015)... 2015  In the pharmaceutical industry, companies want to ... quickly uncover new insights, tactics and strategies that will ... --> However, organizations often find it is ... ensure that all rules and regulations are met to ... barrier to efficiently launching market research projects is the ...
(Date:11/24/2015)... , 24. November 2015 Avery ... Pacemaker Systems, ist erfreut, die Berufung von ... bekannt geben zu können. ... --> Foto - ... (Schweden). Von 1984-1986 war er Fellow des ...
(Date:11/24/2015)... Sectra (STO: SECT B) announces ... a multi-year agreement to deploy Breast Imaging PACS ... provide the Breast Center a future-proof platform capable of expanding ... B) announces that Breast Center of Acadiana has ... Imaging PACS in its two freestanding imaging centers. This investment ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... 2015 , ... The hospitals and health systems on this ... care. They have received recognition for excellence from various reputable organizations in areas ... Hospital Review selected hospitals for inclusion based on national rankings and awards from ...
(Date:11/24/2015)... ... 2015 , ... In response to recent news highlighting Oxycodone fraud, Novus Medical ... the United States grew 400 percent between 1999 and 2010, far more than the ... percent of all fatal drug overdoses. (1) , While oxycodone and the extended release ...
(Date:11/24/2015)... ... ... Serenity Point Rehabilitation, a holistic treatment center for substance abuse located in Marne, ... members at their recovery center. The videos highlight some of the various aspects of ... that make their recovery program so unique. , “Making the decision to seek treatment ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... Cleveland University-Kansas City (CU-KC), in Overland Park, Kansas. Benson, a fifth-trimester ... University President Carl S. Cleveland III on October 16. , “Katie is very ...
(Date:11/24/2015)... ... 24, 2015 , ... Autism Speaks, the world’s leading autism science and advocacy ... and the generosity of people around the world. On December 1, supporters can make ... – and share the personal stories behind those gifts. , Just as Black ...
Breaking Medicine News(10 mins):