For Physicians and Hospitals
The SVS PSO is partnering with the FDA and device manufacturers to use 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 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 VQI members, listed below, with several more in development.
Participation in the 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.
How to Participate:
- Join the Vascular Quality Initiative for the relevant VQI Registry.
- Complete and return the relevant project questionnaire to confirm your interest.
Current Medical Device Evaluation projects and site questionnaires:
Bard® LifeStent® Popliteal Stent Project
The Bard® LifeStent® Popliteal Stent Project is being conducted to further evaluate the Bard LifeStent for treatment of popliteal artery atherosclerosis.
Medtronic IN.PACT™ Admiral™ DCB ISR Project
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.
TEVAR Dissection Surveillance Project
Lombard Aorfix® Surveillance Project
Other Surveillance Projects:
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 VQI to participate in these projects, contact VQI@m2s.com