Virtue sirolimus-eluting balloon granted breakthrough designation for coronary ISR

Pennsylvania-based health company Orchestra BioMed has obtained FDA breakthrough device designation for its Virtue sirolimus-eluting balloon (SEB), according to a statement issued April 24. Virtue SEB, a drug/device combination product that delivers sustained-released bioabsorbable nanoparticle-encapsulated sirolimus directly to a patient’s artery during balloon angioplasty, works without the need for a drug coating, Orchestra said. It’s intended for use in individuals with coronary in-stent restenosis (ISR), a complication that comprises more than 10% of total interventional cardiology procedures.