FDA Grants De Novo Clearance for Z-Medica ’s QuikClot Control+ Only Non-Absorbable Hemostatic Dressing for Severe Bleeding in Internal Organ Space

Wallingford, Conn. - Z-Medica, LLC, a leading developer and marketer of hemostatic devices, announces that QuikClot Control+ has been cleared for use by the US Food and Drug Administration (FDA) under the de novo classification process and is designated as a Class II medical device. QuikClot Control+ is the first and only non-absorbable hemostatic dressing cleared for internal organ space use in severely bleeding patients. QuikClot Control+ is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. “This clearance marks another major milestone in the growth of our company and expansion of the QuikClot brand,” says Z-Medica President and CEO Stephen J. Fanning. “Z-Medica has worked tirelessly with the FDA during the de novo process. The availability of QuikClot Control+ will fill a critical unmet need for hospitals across the country.” Uncontrolled bleeding is a major cause of preventable deaths1 and various studies have shown that bleeding-related complications or transfusions due to significant blood loss lead to increased risk of infection,2,3 longer ICU stay,3,4 longer hospital stay,3,4 higher total hospital costs3,4 and increased postoperative morbidity & mortality.3 Safe and intuitive devices like QuikClot Control+ that improve hemorrhage control5 can potentially save lives and re...
Source: JEMS Patient Care - Category: Emergency Medicine Authors: Tags: Patient Care Industry News Source Type: news