Used as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and/or stent treatment.

CONTRAINDICATIONS

There are no contraindications known at this time based on the clinical data.

WARNINGS

Persons allergic to nitinol (nickel titanium) may suffer an allergic reaction to this implant.

PRECAUTIONS

• This product should only be use by physicians trained and experienced in diagnostic and interventional vascular techniques. Standard techniques for interventional vascular procedures should be employed.
• Manipulation of the Zilver Vascular Stent requires fluoroscopic control.
• Do not use power injection systems with the delivery system.
• Before insertion of the dilation catheter, appropriate antiplatelet and anticogulant therapy should be administrated.
• Use in patients with a history of contrast sensitivity is not recommended unless the patient can be adequately premedicated.
• Bench testing suggests that an increased potential for strut fracture may be associated with overlapping of Zilver Vascular Stents in the peripheral vasculature, while animal studies involving implantation of overlapped Zilver Vascular Stents in iliac arteries did not result in any detected strut fractures. Clinical data characterizing the incidence of fractures in implanted Zilver Vascular Stents are not available.
• The long-term outcome following repeat dilatation of endothelialized stents is unknow at present.
• Safety and effectiveness have not been demonstrated in:
• Patients with a history of bleeding diathesis or coagulopathy
• Patients with a history of iliac aneurysm
• Patients with a known pregnancy
• Lesions located within or beyond a bypass graft
• Pediatric patients

Potential adverse events that may occur include, but are not limited to the following:

• Abrupt stent closure
• Allergic reaction to nitinol
• Amputation
• Angina/coronary ischemia
• Arrhythmia
• Arterial aneurysm
• Arterial rupture
• Arteriovenous fistula
• Atheroembolization (Blue Toe Syndrome)
• Death
• Embolism
• Fever
• Hematoma/hemorrhage
• Hypersensitivity/hypertension
• Infection/abscess formation at access site
• Intimal injury/dissection
• Ischemia requiring intervention(bypass or amputation of toe, foot or leg)
• Myocardial infarction(MI)
• Pseudoaneurysm formation
• Pulmonary embolism
• Renal failure
• Restenosis of the stented artery
• Septicemia/bacteremia
• Stent migration
• Stent strut fracture
• Stroke
• Spasm
• Tissue necrosis
• Worsened claudication/rest pain