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Publication Digest: Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium
MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Siontis et al. conducted a systematic review of the clinical evidence supporting 71 high-risk cardiovascular devices before and after market access in the European Union (CE-marking) between 2000 and 2021. The authors aimed to assess the quantity and quality of published studies, revealing a notable insufficiency in publicly available data and a lack of randomized clinical trial data published before CE-mark approval, with most studies being non-randomized and conducted in small populations without the provision of power calculations.
Access the full-text article here.