Novel Hemostatic Technology Controls Bleeding in All Cardiac Surgical Procedures

S. FDA clearance for expanded indications, allowing for its application across a broader patient population and a wider range of surgical procedures.

Teleflex Incorporated’s (Wayne, PA, USA) QuikClot Control+ Hemostatic Device has received FDA clearance to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding after a sternotomy, enabling its use for the management of all forms of bleeding during cardiac surgeries by clinicians. Given that Teleflex research indicates over 600,000 open cardiothoracic procedures are conducted annually in the U.S., cardiothoracic and cardiovascular surgeons now have an additional tool to control intraoperative bleeding. The QuikClot Control+ Hemostatic Device has also received expanded intended usage to include patients on anticoagulation/antiplatelet medication, with or without the use of autotransfusion (blood salvage) equipment, and with or without cardiopulmonary bypass systems.

The FDA clearance comes after the successful completion and analysis of the 2021 cardiac investigational device exemption (IDE) study. This study focused on the percentage of patients who achieved hemostasis within the initial 10 minutes of hemostatic application and compression at the bleeding site, as well as safety outcomes. The study found that the QuikClot Control+ Hemostatic Device surpassed standard gauze in achieving clinical hemostasis for mild and moderate cardiac surgery bleeding, with no significant difference in safety outcomes. Patients treated with the QuikClot Control+ Hemostatic Device achieved hemostasis at a rate over 20% higher at both 5 and 10 minute intervals compared to those treated with standard gauze.

“We are excited to provide an additional tool to address bleeding control for cardiac surgeons,” said Kevin Robinson, President and General Manager, Anesthesia and Emergency Medicine Division, Teleflex. “We look forward to supporting positive patient outcomes in these procedures through the expanded use potential of our QuikClot Control+ Devices.”

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Teleflex Incorporated