Orchestra BioMed Inc., in partnership with Terumo Corporation, announced Breakthrough Device Designation was granted by the U.S. Food and Drug Administration for the biomedical innovation company’s Virtue Sirolimus-Eluting Balloon in the treatment of below-the-knee peripheral artery disease.
The U.S. FDA’s Circulatory System Devices Panel is undergoing two days of presentations and meetings regarding mortality rates associated with the use of paclitaxel-coated balloons and paclitaxel-eluting stents.
