OrbusNeich said today it won FDA 510(k) clearance for its Sapphire II Pro and Sapphire NC Plus balloon dilation catheters and launched the devices in the US.
The Hong Kong-based company’s Sapphire II Pro features a sub-zero tapered tip and an ultra-low profile for entry through tight lesions, as well as a proprietary XR balloon for crossability and recrossability.
The Sapphire NC Plus is a non-compliant balloon featuring TiFo folding of the balloon material for enhanced crossability in tight lesions, alongside Hydro-X coating for improved lubricity and passibility and an enhanced distal tip for smooth lesion entry.
Both devices won indications for balloon dilation of the stenotic portion of the coronary artery or bypass graft stenosis in patients with coronary ischemia to improve myocardial infusion and for balloon dilation of coronary artery inclusion for the treatment of acute myocardial infarction.
The Sapphire NC Plus is also indicated for the dilation of in-stent restenosis and post-delivery expansion of balloon expandable coronary stents, OrbusNeich said.
“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. 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,” OrbusNeich COO Scott Addonizio said in a press release.
Last November, OrbusNeich launched the latest version of its dual-therapy stent, the Combo Plus, featuring an antibody biological coating designed to promote vessel healing in patients with complex coronary artery disease.