Postmarket Surveillance of Neuroendovascular Devices

Abstract

Endovascular devices have catalyzed a global industry for advanced technologies such as flow diverters and stent retrievers. Though adoption of these devices has skyrocketed over the past 30 years, the regulatory landscape for real‐world monitoring is constantly under revision. Postmarket surveillance is an area of Medical Device Regulation that monitors how devices perform in the real world after regulatory approval. This area of research is underdeveloped globally, with most surveillance relying on passive adverse event data collection from health care systems. The US Food and Drug Administration has not yet established a comprehensive postmarket surveillance strategy for neuroendovascular devices. Postmarket clinical surveillance data are rare; only 4 mandated 522 postmarket neuroendovascular trials exist, and 4 of 14 endovascular registries have published results per ClinicalTrials.gov. The European Union 2017 Medical Device Regulation describes a comprehensive regulatory strategy to address postmarket surveillance, yet it has faced difficult implementation due to resource constraints and concerns such as increased costs and reliance on foreign devices and regulators. More than 50% of manufacturers are planning portfolio reductions, with 33% of the devices from these manufacturers planned for discontinuation. As of April 2022, >85% of 500 000+ previously certified devices were without new certification. In this article, we describe the current regulatory landscape for postmarket surveillance and support the need for a comprehensive, cost‐efficient postmarket strategy for neurovascular devices while proposing several solutions and considerations. An effective postmarket strategy has numerous benefits, such as promoting patient safety, expanding real‐world data collection, and increased efficiency for approving future devices.

Keywords

• aneurysm
• endovascular
• medical device
• neuroendovascular
• regulation
• stroke