Sam Brusco, Associate Editor08.01.23
Teleflex has received U.S. Food and Drug Administration (FDA) clearance for its QuikClot Control+ hemostatic device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding, following a sternotomy.
QuickClot Control+ also gained expanded intended uses for patients on anticoagulation/antiplatelet medication, use with or without autotransfusion equipment, and use with or without cardiopulmonary bypass systems.
The clearance follows completion and analysis of Teleflex’s 2021 investigational device exemption (IDE) study that assessed the percentage of patients who reached hemostasis in the first ten minutes of hemostatic application and compression at the bleeding site, as well as safety outcomes. The study was recently published in The Journal of Thoracic and Cardiovascular Surgery (JTCVS) Open.
The study showed QuikClot Control+ was superior to standard gauze to achieve clinical hemostasis for mild to moderate cardiac surgery bleeding. Study subjects receiving QuickClot Control+ achieved hemostasis at over 20% higher proportion at both five and ten minute intervals compared to standard gauze, as well.
“We are excited to provide an additional tool to address bleeding control for cardiac surgeons,” Kevin Robinson, President and General Manager, Anesthesia and Emergency Medicine Division, Teleflex, told the press. “We look forward to supporting positive patient outcomes in these procedures through the expanded use potential of our QuikClot Control+ Devices.”
QuickClot Control+ also gained expanded intended uses for patients on anticoagulation/antiplatelet medication, use with or without autotransfusion equipment, and use with or without cardiopulmonary bypass systems.
The clearance follows completion and analysis of Teleflex’s 2021 investigational device exemption (IDE) study that assessed the percentage of patients who reached hemostasis in the first ten minutes of hemostatic application and compression at the bleeding site, as well as safety outcomes. The study was recently published in The Journal of Thoracic and Cardiovascular Surgery (JTCVS) Open.
The study showed QuikClot Control+ was superior to standard gauze to achieve clinical hemostasis for mild to moderate cardiac surgery bleeding. Study subjects receiving QuickClot Control+ achieved hemostasis at over 20% higher proportion at both five and ten minute intervals compared to standard gauze, as well.
“We are excited to provide an additional tool to address bleeding control for cardiac surgeons,” Kevin Robinson, President and General Manager, Anesthesia and Emergency Medicine Division, Teleflex, told the press. “We look forward to supporting positive patient outcomes in these procedures through the expanded use potential of our QuikClot Control+ Devices.”