FDA Grants De Novo Clearance for Z-Medica’s QuikClot Control+

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July 12, 2017

Z-Medica, LLC 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.

Z-Medica, LLC, (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.

Z-Medica President and CEO Stephen J. Fanning notes, “This clearance marks another major milestone in the growth of our company and expansion of the QuikClot brand.” He added, “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 reduce healthcare costs.

“In a preclinical study, we saw significantly less blood loss after packing with QuikClot Control+ compared to packing with laparotomy sponges,” 5 said Dr. Joshua P. Hazelton, Director of Trauma Research at Cooper University Hospital, who was the principal investigator in the study.” Hazelton concluded, “The development of a non-absorbable hemostatic dressing that can be used internally during surgery only enhances our ability to stabilize a severely injured patient. Control+ will become a necessary piece of equipment in our trauma bays and operating rooms.”

Domestically, Z-Medica has already obtained several patents for QuikClot Control+ and has numerous patents granted and pending internationally. QuikClot Control+ will be manufactured in the United States.

References

1. Curry N, Hopewell S, Dorée C, Hyde C, Brohi K, Stanworth S. The acute management of trauma hemorrhage: a systematic review of randomized controlled trials. Crit Care. 2011;15(2):R92.
2. Carson JL, Altman DG, Duff A, et al. Risk of bacterial infection associated with allogenic blood transfusion among patients undergoing hip fracture repair. Transfusion. 2999 Jul; 39(7):694-700.
3. Morton J, Anastassopoulos KP, Patel ST, et al. Frequency and outcomes of blood products transfusion across procedures and clinical conditions warranting inpatient care: an analysis of the 2004 healthcare cost and utilization project nationwide inpatient sample database. Am J Med Qual. 2010 Jul/Aug; 25(4):289-296.
4. Stokes ME, Ye X, Shah M, et al. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Serv Res. 2011; 11:135.
5. Koko KR, McCauley B, Hagaman A, et al. Kaolin-based hemostatic dressing improves hemorrhage control from a penetrating IVC injury in coagulopathic swine [published online April 27, 2017]. J Trauma Acute Care Surg. doi:10.1097/TA.0000000000001492

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