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Outcomes Committee
Page Content
Scope of Work
Identify and develop outcomes studies and participate in ongoing efforts to evaluate outcomes for continued advancement of vascular therapies
Continue to advance SVS’ partnership with the FDA Office of Device Evaluation by recommending and implementing solutions for evaluation of vascular devices
Oversee utilization of SVS datasets and FDA Master Access Files (MAFs) including Vascular Registry of carotid procedures dataset, Lifeline Registry of Endovascular Aneurysm Repair Investigational Device Exemption MAF, CLI Performance Goals dataset, and Catastrophic Thoracic Aortic Indications MAFs
Serve as liaison with FDA, CMS, AHRQ, NHLBI and other governmental agencies engaged in vascular disease outcomes research
Serve as liaison with manufacturers and other medical specialties regarding outcomes research initiatives of SVS
2012-13 Charges
- Manage SVS’ FDA Master Access Files established for the evaluation of vascular therapies (AAA surgical controls, thoracic dissection, thoracic transaction, critical limb ischemia dataset)
- Foster partnerships with manufacturers to utilize FDA Master Access Files
- Collaborate with FDA, other specialty societies and industry in response to FDA initiatives, including those regarding inferior vena cava (IVC) filters and thoracic endografts
- Monitor ongoing analyses and publications utilizing Vascular Registry of carotid procedures data
Updated June 2012
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