Healthcare Industry News:  vascular access 

Devices Regulatory

 News Release - February 17, 2016

Z-Medica Receives Expanded CE Mark for QuikClot(R)

WALLINGFORD, Conn., Feb. 17, 2016 -- (Healthcare Sales & Marketing Network) -- Z-Medica®, LLC, a leading developer and marketer of hemostatic devices, announces today they have received an expanded CE Mark for their QuikClot® products in the European Union (EU).

The expanded indication includes the use of the company’s kaolin-based hemostatic products for traumatic bleeding and in conjunction with anti-coagulant therapy.

The indications for use in EU are now the same as they are for the U.S.:

Military/EMS/LE products:
  • Indicated for temporary external use to control traumatic bleeding.
Hospital products:
  • Indicated as a topical dressing for the local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.
Cath Lab Products:
  • Indicated as an adjunct to manual compression and for local management and control of surface bleeding from vascular access sites, percutaneous catheter or tubes utilizing introduction sheaths up to 12 Fr. or 7 Fr. in patients on drug-induced anticoagulant treatment.
“QuikClot has had a presence in the European markets for quite some time,” said Z-Medica’s President and CEO Stephen J. Fanning. “The expanded indication means that millions more throughout Europe now have the full benefit of our life-saving technology.”

About Z-Medica®, LLC

Z-Medica, LLC is a medical device company founded in 2002 that develops fast acting, easy to use hemostatic products that stop bleeding wherever it occurs, making it possible to save lives and improve patient outcomes. 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) chose QuikClot Combat Gauze® as the hemostatic dressing of choice on the battlefield for compressible hemorrhage not amenable to tourniquet use or as an adjunct to tourniquet removal if evacuation time is anticipated to be longer than 2 hours.

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 and

Source: Z-Medica

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