Compression resistance and conformability are crucial stent attributes that help improve vessel patency within tortuous vasculature.

Compression Resistance measured as the force required to compress the fully expanded stent. Compression Resistance measured using a hoop force tester in 37° air. Conformability measured by torque required to achieve a constant curvature target as measured by angular deflection. Bench testing performed by Boston Scientific Corporation. Data on file. N = 3. Express LD tested: 8 x 37 mm. Visi-Pro tested: 8 x 37 mm. Palmaz Genesis tested: 8 x 39 mm. Omnilink Elite tested: 8 x 39 mm. Valeo tested: 8 x 36 mm. Assurant tested: 8 x 40 mm. Bench test results may not necessarily be indicative of clinical performance.

Express LD Stent System features a patented Tandem Architecture™ Stent Design

Micro™ Elements engineered to provide:

• Flexibility during placement
• Conformability upon deployment
• Maximum apposition

Macro™ Elements engineered for:

• Balanced compression resistance
• Strength—even in arterial bifurcations

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

CONTRAINDICATIONS

Generally, contraindications for Percutaneous Transluminal 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, precluding possible stent implantation.
• Patients with excessive vessel tortuosity.
• Patients with perforated vessels evidenced by extravasation of contrast media.

WARNINGS

• 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 surgery 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.
• Prep premounted stent system per instructions given in Operational Instructions. Significant amounts of air in the balloon may cause difficulty in deploying the stent and deflation of the balloon.
• 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.

Potential adverse events (in alphabetical order) that may be associated with the use of intravascular stents include, but are not limited to, the following:

• Abscess
• Aneurysm
• Arrhythmias
• AV fistula
• Bleeding/Hemorrhage
• Death
• Drug reaction or allergic reaction (including to antiplatelet 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 or surgery
• Pseudoaneurysm formation
• Renal Insufficiency or Renal Failure
• Restenosis of the stented artery
• Sepsis/Infection
• Stent migration
• Stroke, TIA, or other cerebrovascular accident
• Thrombosis/Thrombus
• Tissue ischemia/Necrosis
• Vessel injury, including perforation, trauma, rupture, and dissection
• Vessel occlusion