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OrbusNeich's heart device wins US FDA approval, distributor says

Cardiovascular Systems, Inc. said the U.S. Food and Drug Administration cleared OrbusNeich Medical Company Ltd's balloon device for opening clogged blood vessels.

Cardiovascular Systems is the exclusive U.S. distributor of OrbusNeich balloon products, which are inflated inside arteries to clear blockages. The St. Paul, Minnesota-based company said the 1.0-millimeter Sapphire II PRO is the smallest coronary balloon available in the U.S. for difficult-to-treat lesions.

OrbusNeich, which has its corporate headquarters in Hong Kong, develops products to treat heart disease.

Cardiovascular Systems will sell both the 1.0mm to 4.0mm Sapphire II PRO and the 2.0mm to 4.0mm Sapphire NC Plus non-compliant coronary balloons on a limited basis.

The company expects that OrbusNeich's full portfolio of balloon products will be available in the U.S. throughout 2018 and 2019.