PS234. A Novel Secure Vessel Occluder for Minimally Invasive and Percutaneous Treatments

Abstract

Objectives: Secure vessel occlusion is critical to the success of all surgical and interventional procedures. This study tested both in vitro and in vivo, the Amsel Vessel Occluder (AVO), a novel occlusion clip device for secure blood vessel closure. The AVO, delivered through a fine (18-gauge) hypodermic needle, transfixes the targeted vessel, and delivers expandable proximal and distal elements on either side of the vessel wall, which lock together for secure vessel occlusion. Methods: In vitro device testing was conducted on 5mm silicon tubing. Standard corrosion analysis, material biocompatibility, and cytotoxicity were performed on the implantable elements. In vivo studies on three swine compared safety and efficacy of the AVO with the medium/large Ligaclip (J & J) for 1 week. The targeted vessels (carotid/femoral arteries; jugular/femoral veins) were divided between two AVO or two Ligaclips. Results: In vitro testing (n ¼ 11) confirmed a holding pressure of 450 mmHg (11 of 11), excellent clip closure repeatability (11 of 11), and release mechanism function (11 of 11). Once applied, the AVO was secure and could not be dislodged (none of 11). The Ligaclip was easily dislodged (11 of 11). No corrosion was observed, and material biocompatibility and cytoxicity (n ¼ 12) were within accepted ranges. In vivo studies (six arteries; six veins) confirmed easy AVO application and superiority in security. The AVO showed no postoperative bleeding (AVO, zero of six), whereas one Ligaclip dislodged, resulting in a fatal hemorrhage 16 hours after surgery (Ligaclip, one of six). Conclusions: The AVO is simple to deploy and securely maintains occlusion by transfixing the targeted vessel, unlike the widely used, nontransfixing Ligaclip that has a tendency to dislodge. As such, the Amsel secure vessel occluder opens up numerous treatment opportunities in both the venous and arterial systems to minimize open, laparoscopic, robotic surgical, and interventional procedures, and reduce patient morbidity.