Abstract

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Abstract                                                                                                                      

Purpose: In acute ischemic stroke for large vessel occlusions, delayed or failed access to intracranial occlusions has a negative impact on procedural and clinical outcomes.  We attempted to quantify the failures and challenges in mechanical thrombectomy, reproduce the anatomical models, and utilize them for designing and developing medical devices.
Methods: The first part was a systematic literature review from January 2014 to October 2020 where crude failure rates were quantified.  Simultaneously, novel silicone printing technologies were utilized for recreating specific challenging anatomical models.  Finally, a series of iterative R&D steps were taken to test prototypes of devices to overcome these challenges until a robust solution was identified.
Results: For the literature review, a total of 50 articles met the inclusion criteria, totaling 12,838 interventions. Failure to access the occlusion through transfemoral access occurred in 4.4% of patients, most commonly due to challenging supra-aortic vessel anatomy.  The review was presented at congresses and published in peer-reviewed journals.  Through partnerships under Enterprise Ireland, 3 novel and realistic silicone models were recreated.  Over the course of 3 years, prototypes of varying degrees were evaluated until ad device was finalized in June 2021, and end route to launch in Jan 2022.

Conclusion: Failure to access the occlusion is a significant contributor to failed recanalization, regardless of access routes. Understanding and re-creating these challenges can help create in-vitro models used for developing medical devices that overcome real patient challenges