A Novel Thrombectomy Device: An In Vitro Evaluation of a Prototype Catheter

Abstract

Purpose: This prototype catheter is a newly-developed distal access catheter featuring a self-expanding, flexible, funnel-shaped tip. The purpose of its design is to reduce the risk of thrombus fragmentation during mechanical thrombectomy and improve first-pass recanalization (TICI 3). In this experimental setup, we preclinically evaluated the effectiveness and navigability of the new catheter. Methods: A vessel model was filled with a blood-like-viscous medium, and the image was projected with the corresponding vessel area by camera transmission to correspond to the conditions in an angiography. Thrombi from porcine blood were placed into the Arteria Carotis interna of the vascular model and subsequently mechanically thrombectomized with a stent retriever. In the first part, the prototype was compared to a standard distal-access-catheter without using an external catheter. (N = 20 for each catheter). In the second part the prototype was inserted through a guiding catheter (n=11) to determine the navigability performance. Results: In the first experimental series, mechanical thrombectomy was successful 19 out of 20 times (95% success rate) for the prototype catheter versus 15 out of 20 times (75% success rate) for the standard distal-access-catheter. In the second experimental series, the prototype catheter achieved first-pass recanalization 10 out of 11 times (91 % success rate) and 1 out of 11 times at second pass (9%). Conclusion: This series of experiments demonstrated higher first-pass recanalization rates for the newly-developed funnel-shaped prototype featuring a self-expanding tip in comparison to a cylindrical standard distal-access-catheter.