Wednesday, August 02, 2023
Teleflex Incorporated, a leading global provider of medical technologies, has announced that the U.S. Food and Drug Administration (FDA) has cleared the QuikClot Control+™ Hemostatic Device for an expanded indication. The device can now be used to control mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy. This clearance allows clinicians to utilize the QuikClot Control+™ Device for managing bleeding in a wider range of cardiac surgeries.
With this expanded indication, the QuikClot Control+™ Hemostatic Device can be employed across various surgical procedures and patient populations, providing an additional solution for intraoperative bleeding control. Teleflex's research, indicating over 600,000 open cardiothoracic procedures are performed in the U.S. annually, highlights the significance of this clearance for cardiovascular and cardiothoracic surgeons.
The FDA clearance was granted following the completion and analysis of the 2021 cardiac investigational device exemption (IDE) study. The study assessed the percentage of patients achieving hemostasis in the first 10 minutes of applying the QuikClot Control+™ Hemostatic Device and compression at the bleeding site, along with safety outcomes. The study, 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. Moreover, there were no significant differences in safety outcomes. Participants receiving the QuikClot Control+™ Hemostatic Device achieved hemostasis at more than 20% higher proportions at both 5 and 10-minute intervals compared to those using standard gauze.
Kevin Robinson, President and General Manager of Anesthesia and Emergency Medicine Division at Teleflex, expressed enthusiasm about the new clearance, stating, "We look forward to supporting positive patient outcomes in these procedures through the expanded use potential of our QuikClot Control+™ Devices."