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Despite significant advances in coronary angioplasty, the problems of restenosis, chronic total occlusion, diffuse disease, and abrupt closure after the procedure remain to be solved. New devices that address these problems continue to evolve. Although a controlled clinical trial is the ultimate test of any device, rapid device design changes and resource limitations require evaluating which of the new devices justify a full clinical trial. A registry mechanism for this initial evaluation is proposed and detailed. Payment for procedures using new devices is a problem for industry, insurers, hospitals, and physicians. It is proposed that reimbursement be based on the service performed rather than the device used to perform it. Costs beyond the clinical costs should be borne by the sponsor of the device. Financial conflict of interest is a recognized problem in new device evaluation. It is not always practical to insist on exclusion from the evaluation process of individuals with a financial stake in the outcome, but disclosure of the presence of such a financial interest is recommended in the reporting of results.

circulation

Evaluation of emerging technologies for coronary revascularization. Participants in the National Heart, Lung, and Blood Institute Conference on the Evaluation of Emerging Coronary Revascularization Technologies.