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Basic science
Original research
A novel intrasaccular aneurysm device with high complete occlusion rate: initial results in a rabbit model
  1. Christopher T Zoppo1,
  2. Josephine W Kolstad1,
  3. Robert M King1,
  4. Thomas Wolfe2,
  5. Afif Kraitem1,
  6. Zeynep Vardar1,
  7. Aamir Badruddin3,
  8. Edgard Pereira4,
  9. Boris Pabón Guerrero5,
  10. Arturo S Rosqueta6,
  11. Giovanni J Ughi1,
  12. Matthew J Gounis1,
  13. Osama O Zaidat7,
  14. Vania Anagnostakou1
  1. 1 New England Center for Stroke Research, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA
  2. 2 Aurora Neuroscience Innovation Institute, Aurora Health Care, Milwaukee, Wisconsin, USA
  3. 3 Department of Neurology, Community Hospital, Munster, Indiana, USA
  4. 4 Vascular and Interventional Radiology, Biscayne Medical Arts Center, Miami, Florida, USA
  5. 5 Angioteam – Angiosur, Medellín, Colombia, Medellín, Colombia
  6. 6 Research and Development, Galaxy Therapeutics, Milpitas, California, USA
  7. 7 Neuroscience, St Vincent Mercy Hospital, Toledo, Ohio, USA
  1. Correspondence to Professor Matthew J Gounis; matthew.gounis{at}umassmed.edu

Abstract

Background Intrasaccular flow-disrupting devices are a safe and effective treatment strategy for intracranial aneurysms. We utilized high-frequency optical coherence tomography (HF-OCT) and digital subtraction angiography (DSA) to evaluate SEAL Arc, a new intrasaccular device, and compare the findings with the well-established Woven EndoBridge (WEB) device in an animal model of saccular aneurysms.

Methods In a rabbit model, elastase-induced aneurysms were treated with SEAL Arc (n=11) devices. HF-OCT and DSA were performed after implant and repeated after 12 weeks. Device protrusion and malapposition were assessed at implant time and scored on a binary system. Aneurysm occlusion was assessed at 12 weeks with the WEB Occlusion Scale and dichotomized to complete (A and B) or incomplete (C and D) occlusion. The percentage of neointimal coverage after 12 weeks was quantified using HF-OCT. We compared these data to previously published historical controls treated with the gold-standard WEB device (n=24) in the same model.

Results Aneurysm size and device placement were not significantly different between the two groups. Complete occlusion was demonstrated in 80% of the SEAL Arc devices, which compared favorably to the 21% of the aneurysms treated with WEB devices (P=0.002). Neointimal coverage across SEAL Arc devices was 86±15% compared with 49±27% for WEB (P=0.001). Protruding devices had significantly less neointimal coverage (P<0.001) as did incompletely occluded aneurysms (P<0.001). Histologically, all aneurysms treated with SEAL Arc devices were completely healed.

Conclusion Complete early aneurysm occlusion was frequently observed in the SEAL Arc treated aneurysms, with significant neointimal coverage after 12 weeks.

  • Aneurysm
  • Device
  • Technology

Data availability statement

Data are available upon reasonable request. Data are available upon reasonable request to the corresponding author.

https://doi.org/10.1136/jnis-2023-020520

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    Data availability statement

    Data are available upon reasonable request. Data are available upon reasonable request to the corresponding author.

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    Footnotes

    • X @Chris_Zoppo

    • Contributors CZ: Data analysis and statistical analysis. Drafted the manuscript. JK, RMK, AK, ZV, GJU: Responsible for data acquisition, data analysis and statistical analysis. Provided critical editing of the manuscript. TW, AB, OOZ: Provided training and guidance on device use, assisted in study design, and invented the device. Provided critical editing of the manuscript. BP: Input on clinical translation, provided material evidence of clinical usage, critically edited the manuscript. ASR: R&D engineer who developed and built the prototype devices for these experiments. MJG (guarantor): Responsible for planning, conception and design of the study, acquisition of data, analysis, interpretation of data, and editing the manuscript. VA: Responsible for planning, conception and design of the study, implantation of the devices, acquisition of data, analysis, interpretation of data, and editing the manuscript. The independent guarantor of data integrity and agrees to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors approved the final version of this manuscript to be published.

    • Funding This study was sponsored in part by Galaxy Therapeutics and the Bits-2-Bytes grant from the Massachusetts Life Sciences Center. The content is solely the responsibility of the authors and does not necessarily represent the official views of the sponsor.

    • Competing interests CTZ, JK, RMK, ME, and VA declare no competing interest. TW, AB, EP, and OZ: co-founders of Galaxy Therapeutics. ASR: employee of Galaxy Therapeutics. BP: Consultant for Medtronic, Microvention, Cerenovus and MIVI NeurosciencesGJU: Employee of Gentuity LLC. MJG: 1. Consultant on a fee-per-hour basis for Alembic LLC, Astrocyte Pharmaceuticals, BendIt Technologies, Cerenovus, Imperative Care, Jacob’s Institute, Medtronic Neurovascular, Mivi Neurosciences, phenox GMbH, Q’Apel, Route 92 Medical, Scientia, Simcerre, Stryker Neurovascular, Stryker Sustainability Solutions, Wallaby Medical; holds stock in Imperative Care, InNeuroCo, Galaxy Therapeutics, Kapto, Neurogami and Synchron; 2. Research support from the NIH, the United States–Israel Binational Science Foundation, Anaconda, ApicBio, Arsenal Medical, Axovant, Balt, Cerenovus, Ceretrieve, CereVasc LLC, Cook Medical, Galaxy Therapeutics, Gentuity, Gilbert Foundation, Imperative Care, InNeuroCo, Insera, Jacob’s Institute, Magneto, MicroBot, Microvention, Medtronic Neurovascular, MIVI Neurosciences, Naglreiter MDDO, Neurogami, Q’Apel, Philips Healthcare, Progressive Medical, Pulse Medical, Rapid Medical, Route 92 Medical, Scientia, Stryker Neurovascular, Syntheon, ThrombX Medical, Wallaby Medical, the Wyss Institute and Xtract Medical; 3. Associate Editor of Basic Science on the JNIS Editorial Board. OOZ: Consultant for: Stryker, Cerenovous, Penumbra, Medtronic; Research Grant: Stryker, Cerenovous, Penumbra, Medtronic, Genentech, MicroVention; PI: Investigator Initiated trials: TESLA Trial, PI: PICASSO Trial, NIH StrokeNet: Endovascular Committee, StrokeNet Steering Committee; PI: Sterling Aneurysm Registry; Steering Committee: ASSIST Registry, EXCELLENT Registry; Investor: Neuro Technology Investors (NTI)Co-Founder: Galaxy Therapeutics.

    • Provenance and peer review Not commissioned; externally peer reviewed.