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Z-Medica, LLC Announces Expanded CE Indications for QuikClot Hemostatic Dressings Supporting Broader Use in Surgical Wound Care


4/24/2013 9:09:33 AM

WALLINGFORD, Conn., April 24, 2013 /PRNewswire/ -- Z-Medica®, a leading developer and marketer of hemostatic agents, announced newly expanded CE indications for QuikClot® Hemostatic Dressings today. The expanded indications support the use of QuikClot® products as an adjunct to manual pressure for the temporary control of moderate external bleeding from surgical wounds or cuts and lacerations during operative and postoperative care.

The expanded indications for QuikClot® Hemostatic Dressings position these products for use within subcutaneous tissue which will impact how bleeding is controlled in procedures such as cosmetic plastic surgery, breast augmentation and reconstruction, dermatological procedures like Mohs micrographic surgery and punch biopsies, epicardial pacemaker placement, and burn and wound debridement. According to the World Health Organization, there are more than 230 million surgical operations performed globally each year.i Controlling bleeding in surgical procedures is essential for minimizing the length of the procedure, reducing the risk of complications, reducing the cost to patients and medical facilities and improving overall patient outcomes.

"Each year millions of people are at risk for bleeding events on the operating table. These expanded indications mean that more patients will have access to the critical benefits of QuikClot® in the treatment of bleeding associated with surgical wounds, offering important advantages for both patients and surgeons," said Doug Jones, Vice President of International Business at Z-Medica®.

QuikClot® products for hemostasis are now in their third generation and are impregnated with a mineral called kaolin that has been clinically shown to accelerate the body's natural coagulation cascade, without causing any exothermic reaction. Kaolin is a naturally-occurring, inert mineral that does not contain any botanicals or biological material. QuikClot® Hemostatic Dressings present many advantages in the surgical setting. They are engineered to be flexible in order to conform to any size or shape wound, and are non-adherent so they can be removed without disturbing the integrity of a clot that has been formed. They also offer easy storage with no need for refrigeration and do not require extensive training to use.

"Our research related to QuikClot® has demonstrated significant advantages for both patients and surgeons for controlling bleeding in surgical wounds. These expanded indications will help more patients have access to the convenience and proven superior efficacy of QuikClot® for a range of needs in the years ahead," said Doug Kay, Director of Marketing for Z-Medica®.

QuikClot products are used to treat bleeding events around the world by healthcare professionals, law enforcement, first responders, adventure and outdoor sports enthusiasts, veterinarians, and others. Z-Medica® has an established relationship with the U.S. Department of Defense and QuikClot Combat Gauze® is used by all branches of the U.S. military for treatment of severe hemorrhage on the battlefield. The company's products are credited with helping thousands of people survive blood loss events every year.

About Z-Medica® LLC

Z-Medica® LLC is a medical device company founded in 2002 developing fast acting, easy to use, hemostasis products that stop bleeding wherever it occurs, making it possible to save lives and improve patient outcomes. The company manufactures and markets a portfolio of QuikClot® hemostasis products for use by healthcare professionals, first responders, law enforcement officers, consumers and the military.

Based on tests conducted by the Naval Medical Research Center and the U.S. Army Institute for Surgical Research, the Committee on Tactical Combat Casualty Care (CoTCCC) recommended QuikClot Combat Gauze® as the hemostatic agent for the Department of Defense and for use by all U.S. Military Forces as the first line treatment of traumatic bleeding. QuikClot® products are developed and manufactured in the United States. Z-Medica® LLC is a privately-held company based in Wallingford, CT. For more information, visit www.z-medica.com.

iHaynes A, Weiser T, Berry W, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009;360:491-9. doi:10.1056/NEJMsa0810119. http://www.nejm.org/doi/full/10.1056/NEJMsa0810119#t=abstract

SOURCE Z-Medica LLC



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