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

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.

The HTA Core Model ® —10 Years of Developing an International Framework to Share Multidimensional Value Assessment

“…Although pharmaceuticals enter the European market at one time, medical devices and procedures enter the European health care market in a time span of 1 to 5 (and even more) years after European conformity marking [29,30]. The time taken for the diffusion of medical devices across countries has an important impact on the aim to reduce redundancy.…”

Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study

“… 22 In a study of 10 devices reimbursed in Austria, Wild and colleagues found that evidence available at the time of CE marking are more often case series or small feasibility trials, compared with the controlled trials and large prospective cohort studies used as the basis for FDA approval. 41 In turn, low rates of publication and lack of high quality evidence may adversely impact patient outcomes. Nieuwenhuijse and colleagues found that innovative and well known hip and knee replacement prostheses were widely implanted despite a lack of high quality evidence supporting their use; several of these devices were also associated with inferior survival and higher rates of revision.…”

Drugs and Devices

“…NBs as private companies not only compete from a pricing standpoint for approval contracts, but may be reluctant to disapprove devices for fear of losing an ongoing relationship with a manufacturer who hires them. A lack of centralization makes safety data more difficult to collate, and in any case, data submitted for high-risk devices to the NBs is considered “commercially confidential,” and is not available to the public 2 , 41 , 42 .…”

“…Controversy persists about the differences in U.S. and EU regulatory processes, costs, and the time it can take for a DAD to proceed from concept to approval under the regulations of each. A frequently held assertion is that slower FDA approval processes deprive American citizens of effective DADs that are available to Europeans (2) , and critics have characterized FDA processes as “slow, risk averse, and expensive” (3) . However, the Institute of Medicine determined that current FDA pre-marketing procedures for medical devices are insufficient to assure device safety, particularly those approved largely on their similarity to previously cleared “predicate” devices, rather than on prospective, randomized clinical trials (4) .…”