IRVINE, Calif., June 28, 2012 /PRNewswire via COMTEX/ -- 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 LLCBrolex 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
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 LLCBrolex 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
