Vascular Restorer CoCr Instructions D'utilisation page 3

therapies for living
to predetermined diameters and the stent is dilated. On either end of the balloon, two radiopaque markers
are included so as to delimit the stent's length, and help the user to know the location when the device is
inside the patient.
The system ends in a distal tip, it is round-shaped and atraumatic to avoid damaging the arteries during
advancement.
Contents
- A peripheral stent system consisting of the stent pre-mounted in its delivery system (balloon ca-
theter). The stent is protected by a sheath and introduced in a dispenser and sterile pouch.
- A card with a compliance curve showing the working pressure range.
- An implant card.
- A leaflet with instructions for use.
2. Indications
The peripheral stent system is indicated for the treatment of de
in protected peripheral arteries located under the aortic arch; that is, the iliac artery and the deep femoral
artery or proximal femoral artery, and for palliation of biliary tract malignant stenosis with a nominal diam-
eter ranging from 5 and 10 mm.
3. Contraindications
Patients with a contraindication for anticoagulant/antiplatelet therapy.
Patients clearly diagnosed as allergic to heavy metals.
Patients with lesions that prevent full inflation of the angioplasty balloon or the correct implantation of the
stent.
Presence of recent undiluted, disorganized thrombus or of embolic material.
Unprotected vascular regions, exposed to potential risk of external impact that might cause the stent to
crush.
Renal failure or allergy to contrast media.
Severe ascites.
Threat of vital lateral branch occlusion.
4. Warnings
- Stents must only be implanted in hospitals equipped with emergency facilities and staff able to
switch the operation to open surgery, or failing this in hospitals with such services close at hand.
- The product must only be used by physicians well trained in angioplasty techniques, acquainted with
percutaneous intervention and stent implantation.
- This device is designed and intended for single use in only one patient. DO NOT RESTERILIZE OR REUSE.
Reutilization of the product in another patient may cause crossed contamination, infections or trans-
mission of infectious diseases. Reutilization of the product in another patient may cause alterations
thereof and limit its effectiveness.
- The product is supplied sterile. Check the expiry date and do not use products which have passed
this date.
- Administer the adequate therapy to the patient: anticoagulants, vasodilators, etc., in accordance with
the intravascular catheter insertion protocol.
- Use aseptic techniques when removing the product from its primary packaging.
- Do not dry with gauze.
- Do not expose the delivery system to organic solvents.
- Do not use oily or high-viscosity contrast media which are unsuitable for intravascular use.
- Do not use air or gaseous media to inflate the balloon, it must be inflated with a mixture of saline and
contrast media (preferably 1:1 or in the case of large balloons 2:1).
- Select the right size in diameter and length according to the size of the lesion observed fluoroscopically.
INSTRUCTIONS FOR USE
PERIPHERAL STENT SYSTEM CoCr
novo or restenotic
atherosclerotic lesions
restorer
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