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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.


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SOURCE Brolex LLC
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