OrbusNeich® Announces FDA PMA Approval for the Scoreflex® NC Scoring PTCA Catheter

HONG KONG [January 20, 2022] – OrbusNeich Medical Co. Ltd. has announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for the Scoreflex® NC Scoring PTCA Catheter.

The Scoreflex NC is a scoring PTCA catheter indicated for the de novo stenotic portion of a coronary artery and in-stent restenosis in coronary arteries in patients evident with coronary ischemia, for the purpose of improving myocardial perfusion.

A pivotal clinical study was performed in the U.S. in twelve investigational sites, with 200 patients being treated. The results of the Scoreflex NC – Scoring PTCA Catheter Clinical Study support the acute safety and device success and its intended use as a dilatation catheter in the stenotic portion of a coronary artery stenosis (≥70% diameter stenosis).

Clinical Trial: Scoreflex NC – Scoring PTCA Catheter – Full Text View – ClinicalTrials.gov

Manuscript: https://bit.ly/3GRforJ

“Since its launch into the global market, outside the US, in 2017, the Scoreflex  NC has become an invaluable addition to the cardiologists’ toolbox for lesions preparation especially in calcified arteries. We are very pleased to receive FDA PMA approval and are confident our product will be well received by US physicians and will have the same impact as seen in other territories.”

Senior Vice President and Chief Commercial Officer, Alain Khair

About the Scoreflex® NC Scoring PTCA Catheter

The Scoreflex NC is a dual-wire balloon system facilitates controlled plaque modification, at lower resolution pressure, to enlarge the lumen. Scoreflex® NC is an extremely useful device for physicians when handling very resistant lesions and with calcifications. The non-compliant balloon device offers safety while dilating calcified lesions; the low crossing profile allows the balloon to track distally. The state-of-the-art shaft technology ensures good pushability of the balloon.

The addition of Scoreflex NC into a physician’s toolbox can assist in simplifying complex cases procedures.  

About OrbusNeich – Pioneers in life-changing technologies

OrbusNeich is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention. Current products include the world’s first dual therapy stents, the COMBO ®Plus and COMBO® Dual Therapy Stents, together specialty balloons, balloons, and microcatheters marketed under the names of Azule®, Scoreflex®, Scoreflex® NC, Sapphire®, Sapphire® II, Sapphire® II PRO, Sapphire® 3, Sapphire® NC, Sapphire® NC Plus, Sapphire® II NC, Sapphire® NC 24, Teleport® and Teleport® Control as well as products to treat peripheral artery disease: the Jade® and Scoreflex® PTA balloons.

OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Florida, USA; Hoevelaken, The Netherlands; Zuchwil, Switzerland; and regional sales offices in Germany, France, Switzerland, Spain, Japan, Hong Kong, Singapore, China; and Malaysia. OrbusNeich supplies medical devices to physicians in more than 70 countries. For more information, visit www.OrbusNeich.com.