Introduction: The Centers for Medicare and Medicaid Services (CMS) offers New Technology Add-on Payments (NTAPs) to promote access to expensive new technologies for Medicare beneficiaries. Through 2016, this program provided over $500 million in payments for 22 technologies, 9 of which were cardiovascular devices. These supplemental payments are intended to help offset the high cost of new technologies that provide a substantial clinical improvement over the standard of care. Our objective was to determine the quality of evidence for efficacy of cardiovascular devices approved for NTAPs and the applicability of these data to Medicare beneficiaries.Methods: Using Food and Drug Administration summaries, we performed a systematic review of all pivotal efficacy studies of cardiovascular devices approved for NTAPs from fiscal years 2001-2016. We abstracted data on the following characteristics associated with the quality of clinical studies and their susceptibility to bias: randomization, blinding, use of controls, use of surrogate or composite endpoints, funding source, conflicts of interest, and demographic and clinical characteristics of the study populations. We also obtained recall data.Results: There were 9 NTAP cardiovascular devices supported by 12 pivotal efficacy studies (1.3 studies per device). Six studies (50%) were randomized, 5 (42%) were blinded, and 6 (50%) included active controls. Study populations were more predominantly male than the Medicare beneficiary population (68% vs. 45%). There were 16 primary endpoints, of which 7 (43%) were surrogates and 5 (31%) were composites. All studies were industry-sponsored, and principle investigators for 8 devices (89%) had direct conflicts of interest (e.g. honoraria, shareholdings). Five devices (55%) had at least one recall, including 3 class I recalls (indicating the highest risk to patients).Conclusions: Approval of cardiovascular devices for Medicare NTAPs is often based on studies that are not randomized, blinded or controlled, may be prone to bias, and may not be generalizable to the Medicare beneficiary population. These devices are often recalled. NTAP determination criteria should be reevaluated to better serve the program purpose, beneficiaries, and resources.