Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device

Launched by MICROVENTION-TERUMO, INC. · Jul 6, 2022

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The following criteria match the FDA-approved indications for use per PMA (P170013)
• • Subjects treated with the LVIS® Device in accordance with currently approved indications for use;
• • Treatment of wide-necked (neck ≥ 4mm or dome to neck ratio \< 2) intracranial saccular aneurysm arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with LVIS device of researched sizes within the last 5 years.
• • (Device models: 212517-LVIS, 212525-LVIS, 213015-LVIS, 213025-LVIS, 213041-LVIS, 214035-LVIS, 214049-LVIS; 212912-LVIS, 212917-LVIS, 212922-LVIS, 212928-LVIS, and 212931-LVIS);
• • Availability of Medical Health Records;
• • Subject whose age is ≥ 18;
• * Appropriate or Waived Consent:
• • 1. For retrospective review: Local Institutional Review Board approves the research as exempt, allowing an all-inclusive retrospective examination of medical records documenting treatments using the study devices and available clinical and imaging follow up;
• • 2. For prospective follow up: Subject or his/her Legally Authorized Representative consents to participation in the study follow up visits up to 5 years, and provides a signed informed consent form as applicable;.
• Exclusion Criteria:
• • Subjects not treated according to the currently approved indications for use