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
2011-12 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 and SIR in response to FDA Public Health Notice regarding retrievable inferior vena cava (IVC) filters
- Monitor ongoing analyses and publications utilizing VR data, including current AHRQ grant
- Monitor ongoing initiatives utilizing data in the CLI performance goals dataset
Reporting Sub-Committees/Work Groups
CLI Performance Goals Work Group
- Publish sliding-scale objective performance goals for new technology in the area of critical limb ischemia (CLI), in cooperation with FDA
ACS-NSQIP Work Group
- Support the implementation of ACS-NSQIP vascular procedure-specific modules by serving as content advisors and experts to ACS-NSQIP leadership and users
Updated July 2011