Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD Consortium.

The quantity and quality of publicly available data from prospective clinical investigations across selected categories of cardiovascular devices, before and after CE approval during the period 2000-2021, was deemed insufficient. The majority of studies were non-randomized, with increased risk of bias, and performed in small populations without provision of power calculations, and none of the reviewed devices had randomized trial results published prior to CE mark certification.