Surmodics SurVeil PMA ‘Not Approvable’: FDA

FDA says a Surmodics PMA application for its SurVeil drug-coated balloon is currently not approvable. A company statement says the agency provided guidance for a path forward, indicating that certain biocompatibility and labeling information should be added to the PMA through an amendment to place it in an approvable form.

“Although the information identified by the agency to put the PMA application in approvable form would require additional testing and analysis, the letter did not question the human clinical data submitted nor request any further clinical data,” Surmodics says.

Company officials say they plan to meet with FDA to discuss the agency letter and then decide on a path forward.

SurVeil is described as a next-generation device for the treatment of peripheral artery disease that includes a proprietary drug-excipient formulation using an innovative process to improve coating uniformity.