OrbusNeich announces FDA clearance and launch of coronary dilatation catheters


OrbusNeich has announced the launch of its Sapphire percutaneous coronary angiography balloon dilatation catheters (Sapphire II PRO and Sapphire NC Plus) following their recent 510k clearance by the FDA. A press release reports that the Sapphire II PRO has been engineered for crossing the most difficult lesions and tracking tortuous anatomy, adding that it is also designed for successful dilatation.

Sapphire NC Plus, according to the press release, is a true non-compliant balloon featuring TiFo (tight fold) folding of the balloon material for enhanced crossability in the tightest lesions, Hydro-X coating for improved lubricity and “passability”, and an enhanced distal tip which allows for smooth lesion entry.

Furthermore, both products are indicated for a variety of uses including: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion; and balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction. Additionally, the Sapphire NC Plus is further indicated for dilatation of in-stent restenosis and post-delivery expansion of balloon expandable coronary stents.

Scott Addonizio, chief operating officer, OrbusNeich, comments: “The Sapphire II Pro and Sapphire NC Plus are tried and proven technology in both the interventional coronary and interventional radiology markets outside the USA.  Entering the US market with our proven coronary dilatation catheters is a long overdue and logical step for our company. Since our establishment in 2005, we have delivered an extensive portfolio of unique products that have changed the lives of patients and their families around the world. Our focus will now include the US market and we are confident our product will be well received.”




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