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(Circulation. 2008;117:714-716.)
© 2008 American Heart Association, Inc.

Editorial

Regulatory Perspective on Embolic Protection Device Approval for Saphenous Vein Graft Stenting With a Single-Arm Trial Using Risk-Adjusted Prediction Model

Robert P. Fiorentino, MD, MPH; Bram Zuckerman, MD; Takahiro Uchida, MD, MSc

From the Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, Md.

Correspondence to Takahiro Uchida, MD, MSc, Center for Devices and Radiological Health, 9200 Corporate Blvd, HFZ-450, Rockville, MD 20850. E-mail takahiro.uchida.md@gmail.com

Key Words: Editorials • embolism • grafting • equipment and supplies • stents • United States Food and Drug Administration • coronary disease

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
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

	Regulatory Approaches to SVG EPDs for PCI

 
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 . . . [Full Text of this Article]

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