OrbusNeich® Announces 510K FDA Clearance for JADE® Over-The-Wire Non-Compliant Peripheral Balloon Dilatation Catheter Series

HONG KONG [January 8, 2021] – OrbusNeich Medical Co. Ltd. has announced that the United States Food and Drug Administration (FDA) has granted clearance for the JADE^® 0.014”, 0.018” and 0.035” OTW non-compliant peripheral balloon dilatation catheter series.

The JADE Percutaneous Transluminal Angioplasty (PTA) OTW Balloon Dilatation Catheter is an over-the-wire balloon catheter for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including obstructed native arteries and synthetic arteriovenous dialysis fistulae, as well as for post-dilatation of balloon expandable and self-expanding stents.

The JADE OTW is a non-compliant balloon designed for high pressure tolerance and balloon dilatation with even pressure distribution for the treatment of complex lesions.  The series comes in both Rapid Exchange (RX) and Over-The-Wire (OTW) systems compatible with standard 0.014”, 0.018” and 0.035” guidewires, and with catheter working lengths ranging from 135 cm to 150 cm and balloon working lengths from 20 mm to 200 mm.

“We are delighted to expand our JADE peripheral interventions portfolio from 0.014” rapid exchange to include the over-the-wire series” said David Chien, OrbusNeich’s CEO. “We are committed to delivering innovative products that can change the lives of patients and their families around the world. The FDA clearance enables us to offer the JADE OTW series to physicians in the US and other countries.  We are confident our product will provide our physician partners with a greater flexibility and  in treatments options for patients.”

The JADE balloon has been clinically evaluated in two recent physician initiated clinical trials* which demonstrated safety and efficacy in the treatment of patients with critical limb ischemia. Both studies showed that the use of JADE is the preferred choice in tackling highly complex infra-popliteal atherosclerotic lesions.  

*https://pubmed.ncbi.nlm.nih.gov/32693707/

*https://pubmed.ncbi.nlm.nih.gov/32401473/

“Over the past year our JADE non-compliant balloon catheter has certainly become the preferred balloon for the treatment of patients with critical limb ischemia, compared to other semi-compliant balloons.  With the launch of the OTW series, we are confident that our products will be able to serve an even larger community,” said Alain Khair, Chief Commercial Officer of OrbusNeich.

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 are the COMBO^® Plus Coronary Stent, together with stents and balloons marketed under the names of AZULE^®, SCOREFLEX^®, SCOREFLEX^® NC, SAPPHIRE^® II PRO, SAPPHIRE^® 3, SAPPHIRE^® II NC, SAPPHIRE^® NC Plus and SAPPHIRE^® NC24 and the TELEPORT^® microcatheter, 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; and Tokyo, Japan. OrbusNeich supplies medical devices to physicians in more than 60 countries. For more information, visit www.OrbusNeich.com