Covered CP Stent - Descending thoracic aorta endovascular stent-graft

Intended purpose

The stent is intended to dilate aortic coarctations, and/or contain conduit disruptions in the right ventricular outflow tract (RVOT), using percutaneous implantation techniques. For treatment of native and/or recurrent coarctation of the aorta in patients with: · 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.