Surmodics has announced that the FDA has designated its Sundance sirolimus-coated balloon (SCB) catheter as a Breakthrough Device under the agency’s Breakthrough Devices programme. The FDA has already designed the sirolimus devices MagicTouch (Concept Medical), Virtue sirolimus-eluting balloon (Orchestra BioMed), and Selution sustained limus release (MedAlliance) as Breakthrough Devices. The Sundance SCB has been [...]