ArticleBMC cardiovascular disorders2014
Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments.
Article in BMC cardiovascular disorders, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 20 citations in OpenAlex.
- Mapping the evidence supporting FDA-authorized digital therapeutics, before and after authorization.NPJ digital medicine · 2026Article
- Variations in the Medical Device Authorization and Reimbursement Landscape: A Case Study of 2 Cardiovascular Devices Across 4 Countries.Circulation. Cardiovascular quality and outcomes · 2025Article
- Advancing Health Equity in the Cardiovascular Device Life Cycle.Circulation. Cardiovascular quality and outcomes · 2025Review
- Lifecycle evaluation of medical devices: supporting or jeopardizing patient outcomes? A comparative analysis of evaluation models.International journal of technology assessment in health care · 2024Article
- Utilization of innovative medical technologies in German inpatient care: does evidence matter?Health research policy and systems · 2023Review
- Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions.Orphanet journal of rare diseases · 2023Review
- Reimbursement decisions for medical services in Austria: an analysis of influencing factors for the hospital individual services catalogue between 2008 and 2020.BMC health services research · 2022Article
- Pre-reimbursement: early assessment for coverage decisions.Wiener medizinische Wochenschrift (1946) · 2019Article
- Premarket evaluation of medical devices: a cross-sectional analysis of clinical studies submitted to a German ethics committee.BMJ open · 2019Observational
- Review times and adverse events for cardiovascular devices.Nature biomedical engineering · 2017Article
- Drugs and Devices: Comparison of European and U.S. Approval Processes.JACC. Basic to translational science · 2016Article
- Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.BMJ (Clinical research ed.) · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEuropean medical device regulation is under scrutiny and will be re-regulated with stricter rules concerning requirements for clinical evidence for high-risk medical devices. It is the aim of this study to analyse the differences between Europe and USA in dealing with risks and benefits of new cardio-vascular devices.
methodsSince no information is available on clinical data used by the Notified Body for CE-marking, data from Austrian pre-reimbursement assessments close to European market approval were used as proxy and compared with clinical data available at time of market approval by FDA in the USA.
results10 cardio-vascular interventions with 27 newly CE approved medical devices were analysed. The time lag between market authorisation in Europe and in the USA is 3 to 7 years. Only 7 CE-marked devices also hold a FDA market approval, 7 further devices are in FDA approved ongoing efficacy trials. For 4 of the CE-marked devices the FDA market application or the approval-trial was either suspended due to efficacy or safety concerns or the approval was denied. Evidence available at time of CE-marking are most often case-series or small feasibility RCTs, while large RCTs and only in rare cases prospective cohort studies are the basis of FDA approvals. Additionally, the FDA often requires post-approval studies for high-risk devices.
conclusionsMarket authorisation based on mature clinical data deriving from larger RCTs and longer follow-ups do not only change the perspective on the risk-benefit ratio, but also secures real patient benefit and safety and assures payers of investing only in truly innovative devices.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.