First-in-Human Trial Evaluates Safety and Efficacy of Rex Medical's Large Bore Closer System
November 7, 2018 — At VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada, Micah Watts, MD, presented findings from the first-in-human clinical trial of the Large Bore Closer vascular sealing system (Rex Medical).
The trial evaluated 23 patients at a single site and assessed the safety and effectiveness of the Large Bore Closer device in sealing femoral arterial access sites at the completion of percutaneous endovascular procedures performed through 10- to 16-F introducer sheaths. The primary safety endpoint is a composite of 60-day access site closure-related major complications.
Additionally, an interim safety analysis was performed with a primary safety endpoint of freedom from 30-day major adverse events, which was achieved in all 23 intention-to-treat patients.
The primary effectiveness endpoint was measured by time to hemostasis (TTH) after deployment of the device. Thirteen patients were treated without heparin with a mean TTH of 1:02 minutes (standard deviation [SD], 2:12 min) and 10 patients were treated with intravenous heparin (mean activated clotting time at deployment, 218 seconds; SD, 44.8 seconds) with a mean TTH of 2:12 minutes (SD, 3:51 minutes).
These findings confirm the safety and performance of the Closer Large Bore vascular sealing system as assessed in the study population. Preliminary results of the 23-patient Large Bore Closer first-in-human trial confirm the safety and effectiveness of the device when used in patients undergoing endovascular arterial procedures using 10- to 16-F introducer sheaths.
As summarized in the VIVA announcement, The Large Bore Closer device delivers a fully resorbable sealing mechanism to the femoral arterial access site. The sealing mechanism is composed of an intravascular patch and two extravascular spheres connected via two strands of suture. After deployment, the patch remains intravascular, and the two spheres remain extravascular until absorbed. Hemostasis is achieved by the mechanical means of the patch closing the arteriotomy from inside of the puncture. The Large Bore Closer system features an intuitive tightening mechanism that facilitates proper technique for delivery and deployment of the absorbable mechanism.