The FDA approval expands the use of QuikClot Control+ haemostatic device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy, including patients on anticoagulation or antiplatelet medication
The US FDA expands use of QuikClot Control+ device. (Credit: HeungSoon from Pixabay)
US-based medical technology company Teleflex announced that the US Food and Drug Administration (FDA) has approved the expanded use of QuikClot Control+ haemostatic device.
The FDA approval expands the use of QuikClot Control+ to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy.
In addition, it includes the use with patients on anticoagulation or antiplatelet medication, regardless of autotransfusion equipment, and cardiopulmonary bypass systems.
Teleflex said that the expanded approval enables clinicians to use the haemostatic device for controlling all bleeding in cardiac surgical procedures.
Also, it enhances device access across a wider patient population and surgical procedures.
Teleflex anaesthesia and emergency medicine division president and general manager Kevin Robinson said: “We are excited to provide an additional tool to address bleeding control for cardiac surgeons. We look forward to supporting positive patient outcomes in these procedures through the expanded use potential of our QuikClot Control+ Devices.”
The expanded FDA approval follows the completion and analysis of the 2021 cardiac investigational device exemption (IDE) study.
The study assessed the percentage of patients achieving haemostasis in the first 10 minutes of haemostatic application and compression at the bleeding site, along with safety outcomes.
In the IDE study, QuikClot Control+ showed superiority in achieving clinical haemostasis for mild and moderate cardiac surgery bleeding, compared to standard gauze.
The participants treated by the device achieved haemostasis at more than 20% higher proportion at both five- and 10-minute intervals, with no significant difference in safety outcomes.
Teleflex obtained the QuikClot Control+ device through the acquisition of bleeding control solutions provide Z-Medica, in December 2020.
Along with QuikClot Control+, Teleflex also obtained the QuikClot and Combat Gauze brands, which leverage an advanced technology that contains gauze impregnated with kaolin.
QuikClot Control+ is the first haemostatic dressing designated for temporary control of class III or class IV bleeding in the internal organ space, said the medical technology company.