Teleflex announced the completion of patient enrolment in a clinical study evaluating the performance of the QuikClot Control+ Hemostatic device for mild to moderate (class I and II) bleeding in cardiac procedures as compared to standard gauze.
The primary efficacy endpoint of this prospective, randomised, controlled Cardiac IDE study is the rate at which subjects achieved haemostasis through 10 minutes of haemostatic application and compression at the bleeding site. The secondary efficacy endpoint is the proportion of subjects achieving haemostasis measured at five and 10 minutes. The study enrolled 231 patients across seven investigational sites in the US and completed enrolment three months ahead of schedule.
The principal investigators of the Cardiac IDE study include Mubashir A Mumtaz, chief of cardiothoracic surgery and surgical director of the Structural Heart programme at UPMC Central Pennsylvania, Harrisburg, USA, and Marc Moon, section chief of cardiac surgery, at Washington University School of Medicine, St Louis, USA and past president of the American Association for Thoracic Surgery.
“We are pleased to participate in this study to explore the use of the QuikClot Control+ Hemostatic device in cardiac surgery,” said Mumtaz. “We look forward to sharing the results of its use in various aspects of cardiac surgery including coronary artery bypass grafting (CABG), valve repair/replacement, and thoracic aortic surgeries.”
The QuikClot Control+ Hemostatic device is the first US Food and Drug Administration (FDA)-cleared haemostatic dressing indicated for severe (Class III and IV) bleeding in the internal organ space and is currently commercially available in the USA. The product is considered an investigational device for clinical evaluation in the Cardiac IDE study.
“More than 600,000 cardiothoracic procedures are performed in the USA each year, according to Teleflex research,” said Kevin Robinson, president and general manager, Anesthesia and Emergency Medicine Division, Teleflex. “Our goal is to offer surgeons another tool to support positive patient outcomes in these procedures. We anticipate submitting a 510(k) filing for expanded use of the QuikClot Control+ Device following completion of the study analysis.”