FDA hid Stryker Atlas aneurysm stent poor efficacy in aneurysm occlusion

Aneurysm treatment may not result in complete aneurysm occlusion. Incomplete aneurysm occlusion increases the risk for aneurysm recurrence and rupture. Extent of aneurysm occlusion is rated as complete (1), partial (2), and incomplete (3). The rating of aneurysm occlusion is prone to bias. Physicians tend to rate their own aneurysm occlusion better than an independent adjudicator. Therefore, in aneurysm trials, the FDA requires the use of core lab for adjudication. Stryker used University of California, San Francisco, core lab for Interventional Neuroradiology. Most core labs used multiple about 3 independent adjudicators. UCSF only used one doctor There were concerns about UCSF core lab adjudication of Atlas trial and therefore the FDA staff audited his aneurysm occlusion rating. The FDA staff found that they disagreed with UCSF core lab in half the cases and in every one of those cases, UCSF core lab physician graded better. The FDA OHT5 Chief Medical Officer was skeptic and initiated a separate audit. However, in a blinded audit, the FDA Chief Medical Officer disagreed with UCSF core lab in 60% of the cases and in every one of those cases, the UCSF cor lab graded better.

However, the FDA still approved Atlas. Furthermore, the FDA did not include the discrepant results in the labeling. Physicians rely on the FDA trial results and publications regarding the efficacy of devices. Without the true efficacy, physicians will use the Atlas stent more often than competitors which may provide better outcomes.