Cardiovascular Systems, Inc which is a medical device company curating and developing breakthrough interventional treatment systems for patients with peripheral and coronary artery disease announced that the U.S Food and Drug Administration has offered 510(k) clearance for OrbusNeich 1.0mm Sapphire II PRO coronary balloon.
OrbusNeich’s 1.0mm Sapphire II PRO, the first and only 1.0mm coronary balloon available in the U.S., offers industry-leading entry and crossing profiles and is precision engineered for crossing and treating extremely tight and complex lesions. CSI announced it is the exclusive U.S. distributor of OrbusNeich balloon products. OrbusNeich is a globally recognized corporation with established balloon technologies in both percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).
David E. Kandzari, M.D., Director of Interventional Cardiology and Chief Scientific Officer, Piedmont Heart Institute, Atlanta, GA, and principal investigator for the Sapphire II PRO U.S. Clinical Study said “With its exceptionally low profile and deliverability, the Sapphire II PRO is an important new tool to enable us to better treat the patients we serve.”