Michael Bruce Horowitz1*, Brandon Repko2, Hieu Le3, Julia Bulova4 and Benjamin Bobo3
Background: This investigational study reports initial results from testing a new type of mechanical thrombectomy device in a porcine model. The novel technical innovation involves the use of two manually expandable wire spheres that are capable of opening between 3-16 mm in diameter independently of one another and moving independently of one another fore and aft along a common shaft over a 5 cm distance.
Methods: The investigational thrombectomy device was introduced and deployed in vivo within the porcine venous and arterial vasculature. Following deployment and device activation within the animal’s vascular system, arteries and veins were surgically explanted and histopathologic examination was conducted to determine the device’s effects on the vascular surfaces. Statistical analysis was not utilized.
Results: Repeated device deployment and use in porcine veins and arteries failed to demonstrate intimal injury (radiographically and histologically) even when the device’s spheres were expanded beyond 100% of the native vessel’s diameter and translated along the vessel’s intima.
Conclusion: This in vivo study of a novel mechanical thrombectomy device has demonstrated no untoward effects on the internal anatomy of instrumented arteries and veins despite active device expansion repeated surface wall fore and aft friction. Future investigations aim to demonstrate that this device can better treat acute, subacute and chronic venous and arterial thromboembolic disease as compared to currently available technologie
Trial Registration: This article does not report the results of a health care intervention on human participants.