Matches in SemOpenAlex for { <https://semopenalex.org/work/W2145291234> ?p ?o ?g. }
Showing items 1 to 81 of
81
with 100 items per page.
- W2145291234 abstract "European 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. Since 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. 10 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. Market 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." @default.
- W2145291234 created "2016-06-24" @default.
- W2145291234 creator A5049025683 @default.
- W2145291234 creator A5064339323 @default.
- W2145291234 creator A5078647216 @default.
- W2145291234 date "2014-11-04" @default.
- W2145291234 modified "2023-10-12" @default.
- W2145291234 title "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" @default.
- W2145291234 cites W1971884032 @default.
- W2145291234 cites W1973779355 @default.
- W2145291234 cites W1996623390 @default.
- W2145291234 cites W2022102342 @default.
- W2145291234 cites W2026214954 @default.
- W2145291234 cites W2030445733 @default.
- W2145291234 cites W2068457041 @default.
- W2145291234 cites W2149235794 @default.
- W2145291234 cites W2321147310 @default.
- W2145291234 doi "https://doi.org/10.1186/1471-2261-14-154" @default.
- W2145291234 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/4232631" @default.
- W2145291234 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/25366498" @default.
- W2145291234 hasPublicationYear "2014" @default.
- W2145291234 type Work @default.
- W2145291234 sameAs 2145291234 @default.
- W2145291234 citedByCount "12" @default.
- W2145291234 countsByYear W21452912342015 @default.
- W2145291234 countsByYear W21452912342016 @default.
- W2145291234 countsByYear W21452912342017 @default.
- W2145291234 countsByYear W21452912342019 @default.
- W2145291234 countsByYear W21452912342022 @default.
- W2145291234 countsByYear W21452912342023 @default.
- W2145291234 crossrefType "journal-article" @default.
- W2145291234 hasAuthorship W2145291234A5049025683 @default.
- W2145291234 hasAuthorship W2145291234A5064339323 @default.
- W2145291234 hasAuthorship W2145291234A5078647216 @default.
- W2145291234 hasBestOaLocation W21452912341 @default.
- W2145291234 hasConcept C142724271 @default.
- W2145291234 hasConcept C144133560 @default.
- W2145291234 hasConcept C160735492 @default.
- W2145291234 hasConcept C162118730 @default.
- W2145291234 hasConcept C162324750 @default.
- W2145291234 hasConcept C17744445 @default.
- W2145291234 hasConcept C199539241 @default.
- W2145291234 hasConcept C2776050585 @default.
- W2145291234 hasConcept C2779703844 @default.
- W2145291234 hasConcept C50522688 @default.
- W2145291234 hasConcept C535046627 @default.
- W2145291234 hasConcept C71924100 @default.
- W2145291234 hasConceptScore W2145291234C142724271 @default.
- W2145291234 hasConceptScore W2145291234C144133560 @default.
- W2145291234 hasConceptScore W2145291234C160735492 @default.
- W2145291234 hasConceptScore W2145291234C162118730 @default.
- W2145291234 hasConceptScore W2145291234C162324750 @default.
- W2145291234 hasConceptScore W2145291234C17744445 @default.
- W2145291234 hasConceptScore W2145291234C199539241 @default.
- W2145291234 hasConceptScore W2145291234C2776050585 @default.
- W2145291234 hasConceptScore W2145291234C2779703844 @default.
- W2145291234 hasConceptScore W2145291234C50522688 @default.
- W2145291234 hasConceptScore W2145291234C535046627 @default.
- W2145291234 hasConceptScore W2145291234C71924100 @default.
- W2145291234 hasIssue "1" @default.
- W2145291234 hasLocation W21452912341 @default.
- W2145291234 hasLocation W21452912342 @default.
- W2145291234 hasLocation W21452912343 @default.
- W2145291234 hasLocation W21452912344 @default.
- W2145291234 hasOpenAccess W2145291234 @default.
- W2145291234 hasPrimaryLocation W21452912341 @default.
- W2145291234 hasRelatedWork W1500763845 @default.
- W2145291234 hasRelatedWork W1754975726 @default.
- W2145291234 hasRelatedWork W2014991019 @default.
- W2145291234 hasRelatedWork W2115660658 @default.
- W2145291234 hasRelatedWork W2406113541 @default.
- W2145291234 hasRelatedWork W2461210154 @default.
- W2145291234 hasRelatedWork W2465115904 @default.
- W2145291234 hasRelatedWork W2469835611 @default.
- W2145291234 hasRelatedWork W4291677557 @default.
- W2145291234 hasRelatedWork W1680140305 @default.
- W2145291234 hasVolume "14" @default.
- W2145291234 isParatext "false" @default.
- W2145291234 isRetracted "false" @default.
- W2145291234 magId "2145291234" @default.
- W2145291234 workType "article" @default.