Hemostatic device developer Z-Medica said today it won FDA de novo clearance for its QuickClot Control+, now indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV bleeding.
The Wallingford, Conn.-based company touted its QuickClot Control+ as the 1st and only non-absorbable hemostatic dressing with clearance for internal organ space in severely bleeding patients, and added that it may also be used for control of severely bleeding wounds including surgical wounds and traumatic injuries.
“This clearance marks another major milestone in the growth of our company and expansion of the QuikClot brand. 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,” prez & CEO Stephen Fanning said in a press release.
Z-Medica said that multiple studies have shown that bleeding-related complications or transfusions due to blood loss increase risk of infection, result in longer hospital says, higher costs and increasted postoperative morbidity and mortality.
“In a preclinical study, we saw significantly less blood loss after packing with QuikClot Control+ compared to packing with laparotomy sponges. 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,” principal study investigator Dr. Joshua Hazelton of the Cooper University Hospital said in a prepared statement.
Last December, Z-Medica said it inked a 3 year, $2.7 million deal to supply the New York City police department with QuikClot belt trauma kits.
The QuikClot belt trauma kit contains the company’s QuikClot combat gauze, a tourniquet, compression bandage and gloves for controlling bleeding in emergency situations, the company said.