Introduction of New Medical Devices: Lessons Learned From Experience With Endovascular Aneurysm Sealing

Progressive Device Failure at Long Term Follow Up of the Nellix EndoVascular Aneurysm Sealing (EVAS) System

“…This experience is a reminder to the vascular community that while we must continue to embrace innovation and technology, we should not do so at the cost of patient safety. 26 The authors note that Nellix EVAS has surprisingly returned to Investigational Device Exemption trials in the form of EVAS 2 and its Conformité Européenne mark in Europe has been re-instated. 27 A post hoc analysis of the EVAS FORWARD trial suggested that a 10 mm proximal and distal seal would be considered as a technically adequate procedure and lead to improved patient outcomes.…”

Evaluating quality in clinical care

“…Perhaps monitoring of novel devices should happen in national registries, similar to the National joint Registry, and devices with poor performance could be highlighted earlier. 12 External initiatives such as Beyond Compliance are set up to assess the relative risk of a new medical product, such as a joint replacement, and ensure it has ongoing monitoring and assessment.…”