{
  "abstract": "Introduction Intrasaccular flow disrupters (IFDs) are increasingly used in endovascular management of intracranial wide neck bifurcation aneurysms (WNBAs). The next generation Saccular Endovascular Aneurysm Lattice (SEAL) system is a self-expanding, dual layered, braided nitinol IFD available in two configurations (SEAL Arc and SEAL Base) without a lead-in marker band. This primary subgroup analysis of the Pre-SEAL First-in-Human Interventional Trial (Pre-SEAL IT; NCT05686733) reports the final clinical and angiographic outcomes of the SEAL system in the management of WBNAs before the investigational device exemption (IDE) pre-marketing approval US based pivotal trial.Methods Pre-SEAL IT is a prospective, multicenter, single arm study, with US based independent imaging core lab adjudication. Primary safety endpoints were major periprocedural stroke, new subarachnoid hemorrhage, or neurologic death up to 12 months. Primary efficacy endpoints were complete (Raymond–Roy occlusion classification (RROC) 1 Woven EndoBridge occlusion scale (WOS) A or RROC 1 WOS B) or adequate occlusion (RROC 1 WOS A, RROC 1 WOS B, or RROC 2 WOS C) without parent artery compromise at 12 months.Results 13 WNBA aneurysms in 13 patients meeting similar inclusion and exclusion criteria to the Woven EndoBridge Intrasaccular Therapy (WEB-IT) IDE pivotal trial were included in this primary subgroup analysis. Technical success (device delivered and deployed as intended) was 100% (13/13). There were no major periprocedural strokes, new subarachnoid hemorrhages, or neurologic deaths. Independent core lab adjudication showed 11/13 patients (84.6%) achieved complete occlusion and 12/13 patients (92.3%) achieved adequate occlusion at 12 month follow-up.Conclusions SEAL intrasaccular flow disruption showed high technical success, an acceptable safety profile, and encouraging 12 month occlusion rates in the treatment of WNBAs.",
  "authors": [
    {
      "affiliations": [
        "Angioteam-Angiosur, Medellín, Colombia"
      ],
      "name": "Boris Pabón Guerrero"
    },
    {
      "affiliations": [
        "Yale University, New Haven, Connecticut, USA"
      ],
      "name": "Victor Torres"
    },
    {
      "affiliations": [
        "Radiology and Diagnostic Imaging, Beaumont Health System, Royal Oak, Michigan, USA"
      ],
      "name": "Alexander Copelan"
    },
    {
      "affiliations": [
        "University of Toledo, Toledo, Ohio, USA"
      ],
      "name": "Syed F Zaidi"
    },
    {
      "affiliations": [
        "Neurology, University of Toledo, Toledo, Ohio, USA"
      ],
      "name": "Hisham Salahuddin"
    },
    {
      "affiliations": [
        "Angioteam-Angiosur, Mendellin, Colombia"
      ],
      "name": "Manuel Patiño"
    },
    {
      "affiliations": [
        "Angioteam-Angiosur, Mendellin, Colombia"
      ],
      "name": "Andres Zapata"
    },
    {
      "affiliations": [
        "Angioteam-Angiosur, Mendellin, Colombia"
      ],
      "name": "Jorge Mútis"
    },
    {
      "affiliations": [
        "Angioteam-Angiosur, Mendellin, Colombia"
      ],
      "name": "Margarita Cardozo"
    },
    {
      "affiliations": [
        "Dr Ziauddin Hospital, Karachi, Pakistan"
      ],
      "name": "Ammad Hussain"
    },
    {
      "affiliations": [
        "NICVD Karachi, Karachi, Pakistan"
      ],
      "name": "Irfan Lutfi"
    },
    {
      "affiliations": [
        "Dr Ziauddin Hospital, Karachi, Pakistan"
      ],
      "name": "Muhammad Ali"
    },
    {
      "affiliations": [
        "Farooq Teaching Hospital, Lahore, Pakistan"
      ],
      "name": "Saima Ahmed"
    },
    {
      "affiliations": [
        "Interventional Radiology, HCA Fawcett Memorial Hospital, Port Charlotte, Florida, USA"
      ],
      "name": "Edgard Pereira"
    },
    {
      "affiliations": [
        "Galaxy Therapeutics INC, Milpitas, California, USA"
      ],
      "name": "Aamir Badruddin"
    },
    {
      "affiliations": [
        "Britton Woodward, Britton Woodward, Knoxville, Tennessee, USA"
      ],
      "name": "Keith Woodward"
    },
    {
      "affiliations": [
        "Neurosurgery, Cedars-Sinai, Los Angeles, California, USA"
      ],
      "name": "Michael J Alexander"
    },
    {
      "affiliations": [
        "Hospital Vall d’Hebron, Stroke Unit, Neurology, Barcelona, Spain"
      ],
      "name": "Alejandro Tomasello"
    },
    {
      "affiliations": [
        "Neuroradiology, Auckland City Hospital, Auckland, New Zealand"
      ],
      "name": "James Caldwell"
    },
    {
      "affiliations": [
        "Galaxy Therapeutics INC, Milpitas, California, USA"
      ],
      "name": "Thomas J Wolfe"
    },
    {
      "affiliations": [
        "Neurosurgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA"
      ],
      "name": "Brian Jankowitz"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Montefiore Health System, New York, New York, USA"
      ],
      "name": "David Altschul"
    },
    {
      "affiliations": [
        "Neuroscience Insitute, Mercy Health St Vincent Medical Center Department of Internal Medicine, Toledo, Ohio, USA"
      ],
      "name": "Darwin Ramirez-Abreu"
    },
    {
      "affiliations": [
        "Neurointerventional Surgery, Dignity Health Mercy Medical Center Redding, Redding, California, USA"
      ],
      "name": "Amit Chaudhari"
    },
    {
      "affiliations": [
        "Neuroendovascular Surgery, Mercy Health St Vincent Medical Center Department of Internal Medicine, Toledo, Ohio, USA"
      ],
      "name": "Osama O Zaidat"
    }
  ],
  "title": "Safety and efficacy of the Saccular Endovascular Aneurysm Lattice (SEAL) system for the treatment of wide neck bifurcation aneurysms: final 12 month results from the primary subgroup analysis of the Pre-SEAL First-in-Human Interventional Trial (Pre-SEAL IT)",
  "uid": "5210b38e-e63a-52a1-a511-de869c3ebcf3"
}