CSI Announces FDA Clearance of the OrbusNeich 1-mm Sapphire II Pro Coronary Balloon

March 1, 2018—Cardiovascular Systems, Inc. (CSI) announced that the US Food and Drug Administration has granted 510(k) clearance for the company's OrbusNeich 1-mm Sapphire II Pro coronary balloon, which is designed for crossing and treating extremely tight and complex lesions.

At launch, CSI will offer both the 1–4-mm Sapphire II Pro and the 2–4-mm Sapphire NC Plus noncompliant coronary balloons on a limited basis. The company anticipates that OrbusNeich's full balloon product portfolio will become available in the United States throughout 2018 and 2019.

In January, CSI announced that it is the exclusive United States distributor of OrbusNeich balloon products. OrbusNeich's balloon portfolio includes devices for both percutaneous coronary intervention and percutaneous transluminal angioplasty.

David E. Kandzari, MD, Director of Interventional Cardiology and Chief Scientific Officer at Piedmont Heart Institute in Atlanta, Georgia, served as Principal Investigator for the Sapphire II Pro United States Clinical Study.

In the announcement, Dr. Kandzari commented, "As physicians, we have continued to advance techniques and expand access to interventional cardiology procedures. As a result, the patients we are treating today have become increasingly complex, with more challenging lesions and anatomy, and with more difficult clinical indications. 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."