VascuFlex® Aortic
Aortic self-expanding nitinol stent system
The VascuFlex® Aortic is a self-expanding stent system for the human aorta and consists of two main components: the self-expanding Nitinol stent with tantalum markers and the co-axial Pull-Back carrier system which is mounted on the stent.
The carrier system is inserted into the body directly, or, if required, via a 12F, 14F, or 16F introducer sheath (length 100 cm) and using a stiff, coated guide wire (0.035“ = 0.89 mm) of 300 cm length and pushed forward to the vessel section to be treated.
By withdrawing the outer catheter of the carrier system, the self-expanding mechanism of the aortic stent is triggered. The aortic stent reaches its required diameter and covers the damaged section of the vessel. If necessary, the aortic stent can be adapted to the vessel wall with the aid of a separate, suitable balloon catheter.
Stent
The aortic stent is made of a self-expanding nickeltitanium alloy. Various diameters (14 to 40 mm) and lengths (70 to 200 mm) allow for optimum adaptation to the section of the vessel to be treated.
At both ends the stent has a closed-cell diamond structure that allows for relatively high radial force, providing good hold for the stent. In the middle of the stent the mesh structure displays open diamond cells which make the stent very flexible.
For better radiopacity whilst positioning as well as for check-ups, 5 radiopaque tantalum markers have been affixed to each end of the stent.
Indication
The VascuFlex® Aortic is indicated for the treatment of dissections, stenoses and other specific lesions of the thoracic descending aorta, the abdominal aorta as well as for treatment of vena-cava syndrome. In any case the anatomical dimensions must match the available stent sizes.
For this reason its application is restricted to adults only.
Indications for the usage of the VascuFlex® Aortic can be regarded as existent in the following cases:
- Dissections (aortal type B and in the area of the kidneys or visceral arteries)
- Aortic coarctations
- Arteriosclerotic aortic stenoses
- Insufficient angioplasty results
- Elastic stenoses from bypass anastomoses
- Endoleaks of type 1a and 1b (stabilization of stent grafts that are either displaying signs of wrinkling or by which, due to insufficient hold, there is a danger of stent migration.)
- Obstructions or upper and lower inflow congestion of the vena cava due to malignant or benign causes (tumour treatment)
Places of indication:
- In the aorta abdominalis, in the straight area of the aorta thoracalis descendens as well as in the aortic arch distal to the exit of the left arteria subclavia
- In the vena-cava in case of upper and lower venous congestion