Saving Limbs and Lives: A Novel Percutaneous Vessel Occlusion Device to Combat Junctional Hemorrhage in Trauma

Junctional hemorrhage remains a challenging injury pattern with high rates of morbidity and mortality. Current available junctional hemorrhage control devices have limited proven benefit. This was a feasibility study in a swine model to evaluate the Amsel SCureTO regarding percutaneous access of a targeted vessel, ability to control distal hemorrhage, restoration of flow, and removal of the device without further surgical intervention.

The device was tested in a swine hybrid trauma model targeting the carotid and femoral arteries. The SCureTO was deployed percutaneously to transfix the femoral arteries with angiographic confirmation. A partial transection injury to the carotid artery was performed and under direct visualization, and hemorrhage was controlled with the SCureTO. The injury was repaired with a shunt. All devices were removed, and vessel patency and lack of bleeding at the occlusion sites were confirmed.

A total of 12 SCureTOs were tested in 5 male swine (sus scrofa). Seven (58%) targeted the femoral artery (4.5 ± 1.0 mm diameter) while 5 (42%) targeted the carotid artery (4.7 ± 0.7 mm diameter). Ten (83%) of SCureTOs completely transfixed and occluded the target vessel, whereas 1 (8%) provided full occlusion with manipulation, and 1 partially occluded the vessel. Average time to placement was 54.3 ± 21.5 seconds. All devices were removed without surgical intervention, and vessels remained patent.

This feasibility study demonstrated successful percutaneous and open deployment to achieve complete vessel occlusion, control of hemorrhage, and device removal with restoration of flow without further surgical intervention. The SCureTO has the potential to solve noncompressible junctional hemorrhage.