The NuDEL System includes a triaxial balloon in balloon designed catheter with a Covered CP Stent mounted on it; which is then covered by a sheath, as an all-in-one system. The catheter tip is tapered permitting safe entry of the access vessel.
- Right Ventricular Outflow Tract (RVOT)
Coarctation of the Aorta (CoA)
Indicated for implantation in the native and/or recurrent coarctation of the aorta on patients with the following clinical conditions:
- Stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or non-invasive imaging, i.e. echocardiography, magnetic resonance imaging (MRI), CT scan;
- Stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular
- 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 or 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 predilatation procedures performed in preparation for transcatheter pulmonary valve replacement.