WALLINGFORD — Z-Medica, a maker of clotting devices used on the battlefield and by first responders, has federal approval for its latest product to be used in operating rooms.
QuikClot Control+ received U.S. Food and Drug Administration approval in July and is now being manufactured and marketed at its world headquarters on Fairfield Boulevard. QuikClot Control+ is designed for surgical use domestically and abroad as a non-absorbable hemostatic dressing approved for patients with severe bleeding.
”This clearance marks another major milestone in the growth of our company and expansion of the QuikClot brand,” said 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.”
Emergency room personnel can slow uncontrolled bleeding in the hospital and the operating rooms, thus reducing bleeding-related complications or transfusions due to significant blood loss that can lead to increased risk of infection, and longer ICU and hospital stays, according to a statement announcing the product launch.
Z-Medica has developed, marketed and produced bleeding control gauze and dressings for health care providers, military personnel, law enforcement, first responders and consumers around the globe for more than a decade.
“Now you can use the product in a hospital setting,” said Thomas Bonaventura, Z-Medica’s marketing advisor. “That’s significant. We’re very excited about the launch. It’s adding to the doctor’s toolbag.”
Pre-clinical studies reported significantly less blood loss after packing with QuikClot Control+ compared to packing with laparotomy sponges, said Dr. Joshua P. Hazelton, director of trauma research at Cooper University Hospital in New Jersey. Hazelton was the lead investigator in the study.
he product will be manufactured in Wallingford, said company spokesman Dave Schemelia.
The company is preparing for the product launch in Orlando this week, and plans to expand its sales and marketing team by about 10 to 12 people, Bonaventura said.
Z-Medica is privately traded and has been on Fairfield Boulevard since 2004. It employs about 80 people
“We’re thrilled they are here,” said town Economic Development Specialist Tim Ryan, who has frequent conversations with the company. “Continued growth is always a good indication of stability.”
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