NuMED | Mounted CP Stent | Which Medical Device

Description

From NuMED

 

This product is distributed in the UK by BVM Medical for world wide distributors please consult the manufacturer.

Mounted CP Stent

The Mounted CP Stent consists of a bare CP Stent pre-mounted on a BIB Catheter. This system allows the physician the flexibility of using the pre-mounted complete system and will save the time required to mount the stent on the catheter. The CP Stent is composed of 0.013? platinum/iridium wire that is arranged in a ?zig? pattern, laser welded at each joint and then over brazed with 24K gold. It allows expansion from 12.0mm to 24.0mm. The CP Stent is pre-mounted on a BIB (balloon in balloon) catheter.

The Mounted CP Stent is 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 Mounted CP Stent

The Covered Mounted CP Stent consists of a Covered CP Stent pre-mounted on a BIB Catheter. This system allows the physician the flexibility of using the pre-mounted complete system and will save the time required to mount the stent on the catheter. This may be critical in some cases of aneurysmal repair or in cases where vascular damage has occurred. The Covered CP Stent is comprised of the bare CP Stent that is covered with an expandable sleeve of ePTFE.

The Covered Mounted CP Stent is 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.

BIB Stent Placement Catheter

The BIB Catheter allows for the controlled expansion of the CP Stent? by utilizing an incremental expansion of the stent. The inner balloon of the BIB Catheter is ½ the diameter of the outer balloon and is 1.0cm shorter in length. When the inner balloon is inflated, the stent expansion begins from the center of the stent. The stent is firmly gripped on to the balloon to allow for fine positioning before the final expansion by inflating the outer balloon. All BIB Catheters are 110cm in length and utilize a 0.035? guidewire.