Navigation Links
Distribution of C SAFE medical device for safer cesarean sections by preventing lacerations to newborns expands domestically and internationally
Date:6/28/2012

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.

(Photo:  http://photos.prnewswire.com/prnh/20120628/LA33156)

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 www.csafe.us.


'/>"/>
SOURCE Brolex LLC
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:
*Name:
*Comment:
*Email:
(Date:5/10/2017)... , May 10, 2017 Global Health ... Latin America , published its 2017 ranking ... ranking is based on extensive data analysis from GHI,s ... largest hospitals database for the region. The GHI database covers ... , offering more than 130 data points for each institution ...
(Date:5/10/2017)... 2017 CSSi, the global leader in patient ... industry, is proud to announce the launch of its ... features both enriched content and a customized layout that ... company,s already well-established position as the top global patient ... many months of hard work, we are delighted to ...
(Date:5/9/2017)... 2017  Oramed Pharmaceuticals Inc. (NASDAQ: ... company focused on the development of oral drug ... Property Office has granted Oramed a patent titled, ... The patent covers Oramed,s invention of an oral ... an incretin hormone that stimulates the secretion of ...
Breaking Medicine Technology:
(Date:5/23/2017)... ... , ... New England Journal Of Medicine Confirms Viability of Rory’s Regulations and ... Staunton Foundation Calls on Health & Human Services, Tom Price to Adopt Rory’s Regulations ... today reported on a new study released on May 21, 2017 in the New ...
(Date:5/23/2017)... ... 2017 , ... The National Council on Strength and Fitness ... organization’s Certified Strength Coach credential has earned accreditation from the National Commission for ... competency of qualified candidates for jobs in the Strength and Conditioning profession. The ...
(Date:5/23/2017)... CA (PRWEB) , ... May 23, 2017 , ... ... Facial Plastic and Reconstructive Surgeon Dr. Kevin Sadati, is pleased to announce a ... in building collagen and elastin in their face, neck, and body through a ...
(Date:5/23/2017)... ... 23, 2017 , ... Drs. Allen Huang and Jeffrey Wang, ... Las Vegas, NV, and the importance of treating it immediately. They are now ... for peri-implantitis, with or without a referral. As experienced periodontists and implant specialists, ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... video chat as a standard feature on its secure clinical communication platform. The ... voice to video depending on the type and urgency of a situation. ...
Breaking Medicine News(10 mins):