A Safety and Technical Feasibility Evaluation of the Arterica Closure Device for Large-Bore Vascular Closure Following Interventional Procedures

As a first-in-human study the study is a safety and technical evaluation. The primary safety endpoint was evaluated at 30 days post procedure and looked at major complications from the study device. The technical success endpoint was evaluated immediately post procedure and looked at the device ability to close the artery. There were 4 study participants enrolled, with a total of 7 procedures completed using the device, since 3 of the 4 subjects had 2 sites requiring closure. All participants were male, over the age of 70. For the technical feasibility endpoint, 6 of 7 procedures met the study definition of technical success. For the safety endpoint, there was 1 SAE related to the study device.