The article by Coolong et al1 in this issue of Circulation identifies potential predictors of 30-day major adverse cardiac events (MACE) after saphenous vein graft (SVG) percutaneous coronary intervention (PCI) with embolic protection devices (EPDs). These predictors, angiographic estimates of plaque volume and SVG degeneration, were derived from patient-level data on 3958 patients enrolled in 6 clinical trials of SVG EPDs. As discussed in their article, the authors have incorporated these predictors into a model that seeks to accurately predict 30-day MACE rates for such devices. The authors make an intriguing proposal that their covariate-adjusted, historically derived model could be used to construct an objective performance goal for the evaluation of novel EPDs. The implementation of such a model seems an attractive goal not only because of savings in time and cost for future clinical trials but also because of the potential to allow effective devices to reach patients more expeditiously. However, putting the model into practice will likely need some additional forethought and further collaborative effort to ensure that the effectiveness and safety of these devices are adequately evaluated. Although the investigators did not submit the actual predictive model within their article, we appreciate this opportunity to provide our insight into how such a model could potentially be integrated into future trials supporting regulatory approval. Article p 790 The Food and Drug Administration (FDA) regulates devices in 3 classes, with the highest-risk devices in class III, moderate-risk devices in class II, and lowest-risk devices in class I. Medical devices in class III support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. These devices reach the market through the premarket approval process. Because of the level of risk associated with class III devices, …