An FDA panel last week issued its recommendations for pre- and post-market studies of flow diverters used to treat brain aneurysms.
The safety watchdog’s neurological devices panel met April 17 to discuss flow diverters, also known as coil embolization devices, which work by diverting blood flow away from aneurysms including large or wide-necked aneurysms. The FDA is not bound by its advisory panels’ recommendations but often follows their lead.
The neurological devices panel recommended that 1-year pre-market study "is sufficient to capture major adverse events" and said 5 years of post-market surveillance "may be necessary to capture other adverse events."
The panel also recommended that clinical trials for the devices be designed using a set of sub-groups including location, size and morphology (wide-neck, saccular, fusiform, dissecting). Other important sub-groups for trial design are the density of perforator vessels from the main cerebral artery, the characteristics of the parent vessel and whether the patient smokes or has high blood pressure, the FDA panel said.
Aneurysms should be divided by size into either "small and medium" or "large and giant," the panel said, but wide-necked aneurysms should not be separated. Randomized trials should be used wherever possible; if not, carefully designed performance goal trials might be used, the panel said.
Performance goal trials should be designed with well-defined questions and target populations and focused on specific aneurysm types, with multiple treatment arms, according to the panel.
In February Medtronic (NYSE:MDT) won approval for its Pipeline Flex device, which it acquired along with Covidien when their $50 billion merger closed in January. The company also inherited Reverse Medical’s Barrel device when it bought Covidien, which acquired Reverse Medical for an unspecified amount last August.
Sequent Medical got a green light in February for an investigational device exemption study of its Web occlusion device.