Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions

The SPEED OPGs define a new, contemporary benchmark for SFA-popliteal interventions utilizing a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision making. It is appropriate to discuss proposals intended for regulatory approval with the FDA to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance.