The Society for Vascular Surgery® (SVS) identifies and develops outcomes research and participates in ongoing efforts to evaluate outcomes for continued advancement of vascular therapies. The SVS Outcomes Committee oversees the Vascular Registry for carotid artery stenting and carotid endarterectomy dataset, the Lifeline Registry of Endovascular Aneurysm Repair Investigational Device Exemption dataset, and the Catastrophic Thoracic Aortic Indications database.
SVS offers the AAA Surgical Control FDA Master Access File from the Lifeline Registry of Endovascular Aneurysm Repair Investigational Device Exemption dataset. Access to this surgical control data from trials for endovascular grafts used to treat abdominal aortic aneurysms is available to manufacturers to support FDA Premarket Approval Applications.
SVS collaborated with FDA, Society of Interventional Radiology, Society of Thoracic Surgeons, American Association for Thoracic Surgery, investigators, and industry to address the problem of defining appropriate controls for endovascular grafts intended to treat acute, complicated Type B aortic dissections and traumatic thoracic aortic transections. SVS offers Master Access Files from the Catastrophic Thoracic Aortic Indications database for use by manufacturers as comparator datasets in support of FDA Premarket Approval Applications.
Posted June 2010