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.
Source: FDA News