Orchestra Bio Breakthrough Status for Virtue Balloon

FDA has granted Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-eluting Balloon (SEB) for treating coronary in-stent restenosis (ISR). “The unique design of Virtue SEB provides a reliable way to apply the proven anti-proliferative, anti-restenotic benefits of sirolimus during balloon angioplasty without the potential hazards of a permanent metal implant or a balloon coating that may produce downstream particulates and micro-emboli,” the company says.

The first-in-class drug/device combination product is designed to deliver sustained-release bioabsorbable nanoparticle-encapsulated sirolimus, a proven drug for preventing restenosis, directly to the artery during balloon angioplasty without the need for a coating, Orchestra BioMed says. “Virtue SEB's ability to reliably deliver sirolimus via bioabsorbable particles directly to the artery with an elution profile comparable to commercially available drug-eluting stents has been demonstrated in extensive non-clinical studies published in a peer-reviewed journal,” it adds.