OrbusNeich, a company based in Hong Kong, is releasing in the U.S., following FDA clearance, its Sapphire II PRO and the Sapphire NC Plus PTCA balloon dilation catheters. Both devices are indicated for dilation of coronary artery or bypass graft stenoses in cases of ischemia, and for opening up coronary artery occlusions following an infarct. The Sapphire NC Plus can also be used according to labeling for treating in-stent restenosis and to stretch open stents within the coronary artery.
Both devices were developed for navigating through particularly challenging blockages, while the Sapphire II Pro is particularly good at traveling through curvy vasculature. The Sapphire NC Plus sports a non-compliant balloon that’s tightly folded into the stent for easier passage through the lesions. The company’s Hydro-X coating is another characteristic helping the catheter of the Sapphire NC Plus to slide through.
“The Sapphire II Pro and Sapphire NC Plus are tried and proven technology in both the interventional coronary and interventional radiology markets outside the US. Entering the US market with our proven coronary dilatation catheters is a long overdue and logical step for our company,” said Scott Addonizio, Chief Operating Officer, OrbusNeich, in a released statement.
Product page: Sapphire II PRO… (there isn’t one for Sapphire NC Plus yet)