Background: Scientific evidence supports decision-making on the use of implantable medical devices (IMDs) in\r\nclinical practice, but IMDs are thought to be far less investigated than drugs. In the USA, studies have shown that\r\napproval process of high-risk medical devices was often based on insufficiently robust studies, suggesting that\r\nevidence prior to marketing may not be adequate. This study aimed to ascertain level of evidence available for\r\nIMDs access to reimbursement in France.\r\nMethods: The objective was to examine the scientific evidence used for IMDs assessment by the French National\r\nAuthority for Health. We collected all public documents summarising supportive clinical data and opinions\r\nconcerning IMDs issued in 2008. An opinion qualifies the expected benefit (EB) of the IMD assessed as sufficient or\r\ninsufficient, and if sufficient, the level of improvement of the expected benefit (IEB) on a scale from major (level I)\r\nto no improvement (level V). For each opinion, the study with the highest level of evidence of efficacy data, and its\r\ndesign were collected, or, where no studies were available, any other data sources used to establish the opinion.\r\nResults: One hundred and two opinions were analysed, with 72 reporting at least one study used for assessment\r\n(70.6%). When considering the study with the highest level of evidence: 34 were clinical non-comparative studies\r\n(47.2%); 29 were clinical comparative studies of which 25 randomised controlled trials (40.3%); 5 were meta-analyses\r\nof randomised controlled trials (6.9%); and 4 were systematic literature reviews (5.6%). The opinions were\r\nsignificantly different according to the study design (p < 0.001). The most frequent design for insufficient EB, IEB\r\nlevel V and IEB level IV was a non-comparative study (10/19, 52.6%; 15/24, 62.5%; and 8/15, 53.3%; respectively). For\r\nthe 30 opinions with no supporting clinical study, 16 (53.3%) were based on an expert-based process, 9 (30.0%)\r\nwere based on the conclusions of a previous opinion (all concluding IEB level V), and 5 (16.7%) reported no data\r\n(concluding insufficient EB for 4 and IEB level V for 1).\r\nConclusions: This study confirmed that level of evidence of clinical evaluation of IMDs is low and needs to be\r\nimproved.
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