Integra Petitions FDA for Reconsideration of Dural Sealant Device

October 6, 2015 – Integra LifeSciences Corp. submitted a petition for reconsideration, in part, of the FDA’s approval of HyperBranch Medical Technology, Inc.’s premarket approval application (“PMA”) for an Adherus AutoSpray Dural Sealant device.  Integra alleged that the device’s instructions for use (“IFU”) contain “false and misleading labeling claims of superiority based on statistically insignificant post-hoc data.”   Based on this claim, Integra requested “a public hearing before a board of inquiry [to] reconsider the PMA for the Adherus Device by re-reviewing the pivotal trial data supporting the PMA, and revising the PMA’s IFU labeling to reflect the pivotal trial data in a truthful and non-misleading way.”

By:  Christopher J. Stankus

View Attachment (PDF)