August 2, 2023 — Teleflex Incorporated, a leading global provider of medical technologies, announced the U.S Food and Drug Administration (FDA) has cleared the QuikClot Control+ Hemostatic Device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy. This allows clinicians to use the QuikClot Control+ Device to control all bleeding in cardiac surgical procedures.
The expanded indications enable device utilization across a wider patient population and breadth of surgical procedures. With Teleflex research showing more than 600,000 open cardiothoracic procedures are performed in the U.S. each year, cardiovascular and cardiothoracic surgeons now have an additional solution for intraoperative bleeding control. The QuikClot Control+™ Hemostatic Device also received expanded intended uses to include use with patients on anticoagulation/antiplatelet medication, use with or without autotransfusion (blood salvage) equipment, and use with or without cardiopulmonary bypass systems.
The FDA clearance follows the completion and analysis of the 2021 cardiac investigational device exemption (IDE) study, which examined the percentage of patients who achieved hemostasis in the first 10 minutes of hemostatic application and compression at the bleeding site, as well as safety outcomes. The study, recently published in The Journal of Thoracic and Cardiovascular Surgery (JTCVS) Open, concluded that the QuikClot Control+ Hemostatic Device was superior to standard gauze in achieving clinical hemostasis for mild and moderate cardiac surgery bleeding. Additionally, there was no significant difference in safety outcomes. Study participants receiving the QuikClot Control+ Hemostatic Device achieved hemostasis at more than 20% higher proportion at both 5 and 10 minute intervals when compared to those receiving 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.”
For more information: www.teleflex.co