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France to Beef Up Clinical Trial Requirements for Flow Diverter Stents
Devices Regulatory Affairs
France’s National Agency for the Safety of Medicines (ANSM) is calling for more exhaustive clinical studies prior to CE marking of flow diverter stents that are implanted to treat intracranial aneurysms.
ANSM said claims for equivalence with one or more devices of another brand in the CE marking process should not apply and said it would pursue stiffer regulations to strengthen evaluation criteria before CE marks are granted.
The agency said all five stent manufacturers are up to date with their regulatory obligations, but the quantity and quality of the available preclinical data was mixed, as some stents had full preclinical data, while others did not.