FDA Clearance and Launch of OrbusNeich Coronary Dilatation Catheters

OrbusNeich has announced the launch of its Sapphire PTCA balloon dilatation catheters following their recent FDA 510k clearance: the Sapphire™ II PRO and the Sapphire™ NC Plus.

Background

A past visitor to our pages, OrbusNeich specializes in what it calls the provision of life-changing vascular solutions. With its long history in coronary artery disease treatment, in 2013 OrbusNeich launched the innovative COMBO Dual Therapy Stent. That product was claimed to be a world first Drug-Eluting Stent (DES) with the unique biological solution for active healing. It was said to accelerate endothelial coverage and control neointimal proliferation through the combination of the proven Pro-Healing Technology with an abluminal sirolimus drug elution delivered from a 90 day bioresorbable polymer.

In November 2016 OrbusNeich launched the new generation COMBO Plus in select countries. COMBO is supported by clinical evidence from the REMEDEE family of studies and several other investigator-initiated studies, totaling over 6,000 patients enrolled across more than 26 countries

Now, specifically engineered for crossing the most difficult lesions and tracking tortuous anatomy, the company introduces Sapphire II Pro. Tailored for successful dilatation, its well-balanced sub-zero tapered tip has an ultra-low profile, providing effortless entry through the tightest lesions. Other features include a proprietary XR balloon for best-in-class crossability and recrossability without compromising durability and robustness.

Secondly, Sapphire NC Plus is a true non-compliant balloon featuring so-called 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.

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

In addition, the Sapphire NC Plus is further indicated for dilatation of in-stent restenosis and post-delivery expansion of balloon expandable coronary stents.

Company 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 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. “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.”

Source: PR Newswire

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