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View article: Performance of the Edwards Sapien 3 bioprosthesis in atrioventricular valve position: a case series
Performance of the Edwards Sapien 3 bioprosthesis in atrioventricular valve position: a case series Open
Background The Edwards Sapien percutaneous valve (Edwards Lifesciences, Irvine, CA, USA) is a promising therapeutic option for congenital atrioventricular disease mostly because of the possibility to accommodate somatic growth with balloon…
View article: How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice
How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice Open
Background In 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the Europ…