OrbusNeich Gains FDA Clearance for Coronary Dilatation Catheters

The FDA has awarded marketing clearance to OrbusNeich’s Sapphire PTCA balloon dilatation catheters — the Sapphire II PRO and the Sapphire NC Plus. 

The Sapphire II Pro has a tapered tip and an ultra-low profile, allowing entry through tight lesions.

Sapphire NC Plus is indicated for dilatation of in-stent restenosis and post-delivery expansion of balloon expandable coronary stents. — Cynthia Jessup