Express® LD Iliac Premounted Stent System

Prescriptive Information

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

INDICATIONS FOR USE
The Express LD Iliac Premounted Stent System is indicated for the treatment of atherosclerotic lesions found in iliac arteries up to 100mm in length, with a reference diameter of 6mm to 10mm.

CONTRAINDICATIONS
Generally, contraindications for Percutaneous Transluminal Renal Angioplasty (PTA) are also contraindications for stent placement. Contraindications associated with the use of the Express LD Iliac Premounted Stent System include:

• Patients who exhibit persistent acute intraluminal thrombus at the treatment site, following thrombolytic therapy
• Patients with uncorrected bleeding disorders or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
• Persons with known allergies to stainless steel or its components (for example nickel)
• A lesion that is within or adjacent to the proximal or distal segments of an aneurysm
• Patients who experience the complication of arterial perforation or a fusiform or sacciform aneurysm during the procedure, preceding possible stent implantation
• Patients with excessive vessel tortuosity
• Patients with perforated vessels evidenced by extravasation of contrast media

WARNINGS
As with any type of intravascular implant, infection, secondary to contamination of the stent, may lead to thrombosis, pseudoaneurysm or rupture into a neighboring organ or into the retroperitoneum. The stent may cause thrombus or distal emboli to migrate from the site of the implant down the arterial lumen.

Persons with allergic reactions to stainless steel or its components (for example nickel) may suffer an allergic response.

Stent placement should only be performed at hospitals where emergency peripheral artery bypass graft can be readily performed.

PRECAUTIONS
The device is intended for use by physicians who have been trained in interventional techniques such as percutaneous transluminal angioplasty (PTA) and placement of intravascular stents.

Caution should be taken with patients with poor renal function who, in the physician’s opinion, may be at risk for a contrast medium reaction.

Stenting across a bifurcation or side branch could compromise future diagnostic or therapeutic procedures, or could result in thrombosis of the side branch.

More than one stent per lesion should only be used when clinically indicated for suboptimal results that compromise vessel integrity and threaten vessel closure, such as edge dissection ≥type B (i.e. bailout). The second implanted stent should also be an Express® LD Iliac Stent, or a stent of similar material composition, for component compatibility.

ADVERSE EVENTS
Potential adverse events (In alphabetical order) that may be associated with the use of this device, but are not limited to, the following:

• Abscess
• Aneursym
• Arrhythmias
• AV fistula
• Bleeding / Hemorrage
• Death
• Drug reaction, allergic reaction (including to antiplatlet agent, contrast medium, stent materials, or other)
• Embolization of device, air, plaque, thrombus, tissue, or other
• Extremity ischemia/amputation
• Hematoma
• Hypotension or Hypertension
• Myocardial infarction
• Need for urgent intervention for surgery
• Pseudoaneurysm formation
• Renal Insufficiency or Renal Failure
• Restenosis of the stented artery
• Sepsis/Infection
• Stent migration
• Stroke, TIA, or other cerebrovascular accidents
• Thrombosis/Thrombus
• Vessel injury, including perforation, trauma, rupture, and dissection
• Vessel occlusion

Please refer to the Directions for Use for clinical data from the BSC MELODIE Clinical Trial prior to use of this product.