Expanded CE mark approval for Z-Medica QuikClot

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Z-Medica has been granted an expanded CE mark for the QuickClot products within the European Union (EU), bringing its indications for use in line with those in the USA.

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

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 utilising introduction sheaths up to 12Fr or 7Fr in patients on drug-induced anticoagulant treatment.