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For Physicians and Hospitals
The SVS PSO is partnering with the FDA and device manufacturers to use SVS VQI to help meet device regulatory requirements. The quality of these devices is important for vascular healthcare, so this is an important aspect of the SVS PSO. Using SVS VQI data for multiple stakeholders is also efficient, so that sites that participate in such projects do not need to enter data twice. Currently, there are post-approval surveillance projects available for SVS VQI members, listed below, with several more in development.
Participation in the SVS VQI is required to participate in these projects. Because these are quality improvement projects in the SVS PSO, and are surveillance of standard clinical practice with FDA approved devices, these are not studies that require IRB approval or informed consent. However, sites are reimbursed for the cost of additional data and follow-up entry that may be required for these projects, and participation is voluntary.
participate in industry projects
Join the SVS VQI for the relevant SVS VQI Registry. Once you’ve registered, you’ll be sent a project questionnaire to confirm your interest.
Current Medical Device Evaluation projects and site questionnaires
The Registry has been designed for both hospital-based practitioners as well as those working in outpatient facilities such as Vein Centers. A range of analytical tools will allow physicians, data managers and facility management to monitor outcomes, all in real time.
The Bard® LifeStent® Popliteal Stent Project is being conducted to further evaluate the Bard LifeStent for treatment of popliteal artery atherosclerosis.
The Medtronic IN.PACT™ Admiral™ DCB ISR Project is being conducted to confirm that IN.PACT Admiral DCBs are safe and effective for treatment of ISR lesions in the superficial femoral and popliteal arteries.
For more information about the TransCarotid Registry (TCAR) surveillance project, click here.
For more information about the CREST2 surveillance project, click here.
For information about how to join the SVS VQI to participate in these projects, contact VQI@fivoshealth.com