NuDEL Delivery System - General aorta endovascular stent-graft

Risk Class

Class III

Product Type

Single Device Product

ARTG Category

General

Start Date

May 31, 2017

Effective Date

February 02, 2021

Name

Intervene Medical Pty Ltd

Name

Numed Inc

Country

United States of America

Address

2880 Main Street, HOPKINTON , New York, 12965

The NuMED NuDEL Delivery System is recommended for stent implantation in the native and/or recurrent Coarctation of the Aorta with the following conditions: • Stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or non-invasive imaging • Stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function • Stenosis of the aorta where balloon angioplasty is ineffective or contraindicated • Stenosis diameter < 20% of the adjacent vessel diameter. Stenosis that would present increased risk of vascular damage of disruption; or aneurysm associated with Coarctation of the aorta Right Ventricular Outflow Tract (RVOT) Indicated for treatment of right ventricle to pulmonary artery (right ventricular outflow tract) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement.