Abstract 280: Strength of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Through Food and Drug Administration (FDA) Priority Review [Session Title: Poster Session PM]

Conclusions and Relevance: Most priority review pathway high-risk cardiovascular devices are approved without a randomized or blinded trial. Noninferiority design and use of surrogate endpoints are common. These devices are frequently subject to recalls.

Source: Circulation: Cardiovascular Quality and Outcomes - April 5, 2018 Category: Cardiology Authors: Jones, C., Dhruva, S. S., Redberg, R. F. Tags: Session Title: Poster Session PM Source Type: research