Cardiovascular Systems Wins Clearance for Sapphire II PRO Coronary Balloon

Cardiovascular Systems received 510(k) clearance for the  OrbusNeich  1.0 millimeter Sapphire II PRO coronary balloon.  CSI is the exclusive U.S. distributor of OrbusNeich balloon products.

The Sapphire II PRO is “an important new tool,” according to David E. Kandzari, director of interventional cardiology and chief scientific officer for the Piedmont Heart Institute, Atlanta, Georgia, who is the principal investigator for the Sapphire II PRO U.S. Clinical Study.

CSI expects to launch OrbusNeich’s full balloon product portfolio in the U.S. in 2018 and 2019.