FDA Expert Panel Considers Trial Designs for Neurological Devices

Most members of the FDA’s Medical Devices Advisory Committee panel on neurological devices said age should not be a consideration for inclusion in a clinical trial, but life expectancy should, and patients with less than one year of life expectancy should be excluded from studies.

The FDA asked the experts to consider whether there are specific rates of adverse events that would raise serious concerns about the safety of a specific device. Some panelists argued there should be a 3 to 5 percent rate limit for death and disabling strokes for unruptured aneurysms and a 10 percent rate for ruptured aneurysms. All panel members said it was important to differentiate between ruptured and unruptured aneurysm cases.

The panel members generally agreed that the widely-used Raymond classification scale, which assesses the degree of aneurysm occlusion, should be used in intracranial aneurysm device trials, but that “novel technologies” may require alternative assessment tools.