The first procedure was performed by Dr Matthew Eagleton from the Cleveland Clinic Foundation, Department of Vascular Surgery, and was procured by Dr Daniel G. Clair, chairman of the Department of Vascular Surgery at the Cleveland Clinic Foundation.
The US Food and Drug Administration (FDA) gave its approval for the Ventana clinical trial under an Investigational Device Exemption (IDE) to be carried out at up to 25 clinical sites in the US and involving 122 patients. The trial is aimed at backing a future premarket approval (PMA) application for the Ventana System for the endovascular repair of juxtarenal and pararenal aneurysms in selected patients. The study's primary endpoints are to assess safety at 30 days and effectiveness at one year, with continuing follow-up to five years.
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