Background The Advanced Thrombectomy System (ANCD) provides a new funnel component designed to reduce clot fragmentation and facilitate retrieval in patients with stroke by locally restricting flow, allowing distal aspiration in combination with a stent retriever (SR).
Objective To evaluate the preclinical efficacy and safety of the ANCD in a swine clot model.
Methods Soft and firm clots were implanted in the lingual and cervical arteries of 11 swine to obtain Thrombolysis in Cerebral Infarction (TICI) 0 blood flow. Mechanical thrombectomy was performed with either a balloon guide catheter+Solitaire 2 stent retriever (BGC+SR, n=13) or ANCD+SR (n=13). TICI flow was evaluated and successful revascularization was defined as TICI 3 (normal perfusion). To characterize safety, a total of 3 passes were performed in each vessel independent of recanalization. Tissues were explanted for histopathological analysis after 3 and 30 days, respectively.
Results First pass reperfusion rates were ANCD+SR: 69% and BGC+SR: 46%. Reperfusion increased after the third pass in both groups (ANCD+SR: 100%, vs BGC+SR: 77%). Recanalization was achieved after an average of 1.4 and 1.9 passes in ANCD+SR and BGC+SR (p=0.095), respectively. Vessel injury was comparable in both groups; endothelial loss at 3 days was the most common injury seen (ANCD+SR: 1.78±1.22; BGC+SR: 2.03±1.20; p=0.73), while other histopathological markers were absent or minimal. Tissues downstream from targeted vessels also showed absence or minimal lesions across both groups.
Conclusions Results in a swine clot model support the high efficacy of the ANCD+SR without causing clinically significant vessel injury potentially related to the new funnel component.
- vessel wall
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Contributors Conception and design: LB, SS, MR, AR, HV, and IG. Procedures in animals: LB. Acquisition of the data: LB and RD. Histological analysis: RD. Analysis and interpretation of the data: LB, RD, MR, and SS. Drafting the article: SS, MR, and IG. Critically revising the article: TA, CC, and RN. Reviewed submitted version of manuscript: all authors. Study supervision: LB.
Funding Anaconda Biomed provided funding for the study. This study was also partially supported by the following public grants: EMP-TU-2016-5296, RTC-2017-6749-1, SNEO: 20161073, NUCLIS: RD17-1-0086, EIT Health: HS PoC 2018-HS-0170.
Competing interests SS, HV, AR, and IG are employees of Anaconda Biomed. LB and RD are employees of CBSET, a not-for-profit research organization, which received research funding from Anaconda Biomed for the reported work. MR is a shareholder in Anaconda Biomed, consultant for Cerenovus, Medtronic, Stryker, Apta Targets, and Vesalio. TA is clinical consultant for Anaconda, Ablynx, Amnis Therapeutics, Cerenovus/Neuravi, Medtronic, and Rapid Medical. RN: Stryker Neurovascular (DAWN trial principal investigator- no compensation, TREVO Registry Steering Committee – no compensation, Trevo-2 trial principal investigator- modest; consultant - significant); Medtronic (SWIFT Trial Steering Committee - modest; SWIFT-Prime Trial Steering Committee – no compensation; STAR Trial Angiographic Core Lab - significant); Penumbra (3D Separator Trial Executive Committee – no compensation); Cerenovus/ Neuravi (ENDOLOW Trial Principal Investigator, EXCELLENT Registry Principal Investigator, ARISE-2 trial Steering Committee – no compensation, Physician Advisory Board, modest); Phenox (PROST Trial Principal Investigator, Physician Advisory Board, modest); Anaconda (Physician Advisory Board, modest); Genentech (Physician Advisory Board – modest); Biogen (CHARM Trial Steering Committee; Physician Advisory Board – modest). Pharmaceuticals (Physician Advisory Board – modest); Allm Inc. (Physician Advisory Board – no compensation); IschemaView (Speaker, modest); Brainomix (Physician Advisory Board, stock options); Sensome (Research Device Use – no compensation); Viz-AI (Physician Advisory Board, stock options); Philips (Research Software Use – no compensation, Speaker - modest); Corindus Vascular Robotics (Physician Advisory Board, stock options); Vesalio (Physician Advisory Board, stock options); Ceretrieve (Physician Advisory Board, stock options); Astrocyte (Physician Advisory Board, stock options). CC is consultant for Sequent Medical, MicroVention, Stryker and Codman.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Data Sharing Statement. The data that support the findings of this study are available from the corresponding author on reasonable request.