Heart Medical Europe B.V.

Stent Characteristics

The CP Stent™ is composed of 0.013” platinum/iridium wire that is arranged in a “zig” pattern that is laser welded at each joint and then over brazed with 24K gold. The 8 zig configuration allows expansion from 12 mm to 24 mm, and the 10 zig configuration allows expansion from 26 mm to 30 mm. The Covered CP Stent™ is comprised of the Bare CP Stent that is covered with an expandable sleeve of ePTFE.

Bare Stent

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 function;
• Stenosis of the aorta where balloon angioplasty is ineffective or contraindicated;
• Stenosis diameter >20% of the adjacent vessel diameter.

Covered Stent

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 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 or disruption;
• Aneurysm associated with coarctation of the aorta.