Introduction/purpose The DAISe System (MIVI Neuroscience, Inc., Eden Prairie, MN) is a novel thrombectomy treatment system intended for acute ischemic stroke. It consists of an expandable, polymer, fiber-based element mounted onto a wire (figure 1) and a thromboaspiration catheter. When deployed, the fiber element acts as a mechanical backstop to usher the thrombus back to the mouth of the aspiration catheter for removal. This preclinical study examined the system’s ability to perform mock mechanical thrombectomy procedures in a porcine model and 3D anatomical flow models and bench experiments.
Materials and methods Exogenous thrombi manufactured from autologous blood were introduced to porcine subjects to simulate ischemic stroke. Blood was centrifuged, allowed to clot, then aliquoted into clot sizes proportional to the target vessel dimensions. The thrombi were delivered into the neurovasculature one at a time, and subsequently retrieved aspiration via a 30 cc syringe and the DAISe System. This was repeated bilaterally in two subjects of 35 kg or greater. Contrast and angiography were used to visualize the vasculature before and after the procedure. Pathological assessment was performed on affected arteries. Additionally, a series of in vivo experiments were conducted including thrombectomy performed with both red and white clots, comparing the DAISe System, the DAISe System with aspiration, and two commercially available stent retrievers.
Results All thrombectomy attempts in the porcine model with the DAISe System and aspiration were effective in removing clot and did not cause significant vascular damage as determined by pathological analysis. Each procedure was relatively rapid, taking no more than ten minutes per clot. In the in vitro thrombectomy test, the DAISe System plus aspiration resulted in the highest rate of success for both red (100%) and white clots (100%). The DAISe System without aspiration along with the Stent Retriever 1 both exhibited clot removal efficiencies of 80% and 60% for red and white clots respectively. Finally, Stent Retriever 2 had a red and white clot retrieval success rate of 60% and 40% respectively.
Conclusion In this preclinical evaluation, the DAISe System successfully removed thrombi when used in junction with aspiration in an animal model. In addition, it demonstrated greater clot retrieval efficiency when used with aspiration in in vitro thrombectomy experimentation.
Disclosures T. Long: None. J. Wolter: 5; C; MIVI Neuroscience, Inc. W. Bichard: None. M. Preul: None.
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