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Medical Devices / Submissions and Approvals

OrbusNeich Gains FDA Clearance for Coronary Dilatation Catheters

June 7, 2017
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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

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