Z-Medica LLC, a Wallingford-based developer and marketer of hemostatic devices, announced today that it has received an expanded CE Mark for its QuikClot products in the European Union.
The letters “CE” appear on many products traded in the European Economic Area and signify that products sold there have been assessed to meet high safety, health, and environmental protection requirements, according to a European Commission website.
The expanded indication includes the use of Z-Medica’s kaolin-based hemostatic products for traumatic bleeding and in conjunction with anti-coagulant therapy.
QuikClot has been in the European markets for quite some time, Z-Medica’s president and CEO, Stephen J. Fanning, said in a news release. “The expanded indication means that millions more throughout Europe now have the full benefit of our life-saving technology,” he said.
Uses in the EU are now the same as they are for the U.S.:
-For temporary external use to control traumatic bleeding.
-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.
-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 in patients on drug-induced anticoagulant treatment.
