Teleflex
(NYSE: TFX)
announced today that the FDA expanded the indication for its QuikClot Control+ device.
The expanded indication for the hemostatic device includes mild and moderate bleeding in cardiac surgical procedures. It also includes bone surface bleeding following a sternotomy. Indication expansion allows clinicians to use QuikClot Control+ to control all bleeding in cardiac surgical procedures. Teleflex says this enables device utilization across a wider patient population and breadth of surgical procedures.
Wayne, Pennsylvania-based Teleflex bought QuikClot Control+ as part of its $500 million acquisition of Z-Medica in 2020. The device also received expanded uses to include patients on anticoagulation/antiplatelet medication. It can treat patients with or without autotransfusion (blood salvage) equipment and be used with or without cardiopulmonary bypass systems.
According to a news release, the FDA clearance follows the completion and analysis of a 2021 investigational device exemption (IDE) study. This study 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.
Data demonstrated superiority for the QuikClot Control+ compared to standard gauze with no difference in safety outcomes. Patients receiving the hemostatic device achieved hemostasis at a more than 20% higher proportion at both five- and 10-minute intervals.
“We are excited to provide an additional tool to address bleeding control for cardiac surgeons,” said Kevin Robinson, president and GM, 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.”