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.:
Indicated for temporary external use to control traumatic bleeding.
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.”
QuikClot is distributed in Ireland by Cardiogenics Ltd