OBJECTIVES: To assess the characteristics and trends of new cardiovascular drugs and medical devices approved by the FDA from 1980 to 2021.

METHODS: We obtained regulatory information for cardiovascular new molecular entities, therapeutic biologics, and cardiovascular medical device premarketing approval applications (PMA) from the Food and Drug Administration (FDA) website. The new drugs and devices were characterized based on FDA regulatory procedures and product characteristics. Descriptive analysis was employed in the analysis of the data.

RESULTS: The FDA approved 163 (8.6% of drug approvals) cardiovascular drugs and authorized 389 (25.6%) new cardiovascular medical device PMA. The number of new cardiovacular drugs declined from 35 (17.8%) in the 1980s to 14 (3.6%) in the 2010s, while the number of cardiovascular PMA authorizations increased from 49 (11.0%) in the 1980s to 119 (35.7%) in the 2010s. The FDA approved 51 (35.2%) new cardiovascular drugs using priority review designation, 7 (3.4%) fast track approval, 4 (3.0%) accelerated approval, and 1 (0.7%) breakthrough therapy designation. The FDA also approved 43 (11.1%) new cardiovascular PMA using expedited review or breakthrough designation. Implantable cardiovascular devices represented 44.5% of all new implantable PMA, and life-sustaining support cardiovascular devices represented 93.6% of all new life-sustaining support PMA.

CONCLUSIONS: New cardiovascular drugs represented less than 9% of all new drugs and new cardiovascular medical device Premarket Approval (PMA) authorization represented over 25% of all PMA approvals during the study period. The number of new cardiovascular drugs decreased while the number of cardiovascular medical devices PMA authorization increased during the study period. Future research could assess the clinical benefit of the new cardiovascular drugs and medical devices marketed in the US in order to evaluate the value of these new treatments and devices in improving patient outcomes.