Dynamic, Innovative Design

HIGH DURABILITY

Venous Wallstent is specifically engineered to provide fracture resistance. It is designed to withstand the forces common in venous anatomy.

BRAIDED ARCHITECTURE

Braided design with Elgiloy® material provides compression resistance in venous anatomy. In addition, its reconstrainability eases placement.

UNIQUE CONFORMABILITY

The stent is designed for optimal conformability so it can be deployed effectively in curved and tapered vessels.

The WALLSTENT RP Endoprosthesis is indicated for use following suboptimal percutaneous transluminal angioplasty (PTA) of common and/or external iliac artery stenotic lesions, which are ≤ 10 cm in length. A suboptimal PTA is defined as a technically successful dilation, judged by the physician to be suboptimal due to the presence of unfavorable lesion morphology such as:

• An inadequate angiographic and/or hemodynamic result as defined by a 30% or greater residual stenosis after PTA, lesion recoil, or intimal flaps.
• Flow limiting dissections post PTA longer than the initial lesion length.
• A 5 mm Hg or greater mean transtenotic pressure gradient post PTA.

CONTRAINDICATIONS

The WALLSTENT RP Endoprosthesis is contraindicated for use in:

• Patients who exhibit persistent acute intraluminal thrombus at the proposed landing site, post thrombolytic therapy.
• Patients who experience the complication of arterial perforation during the angioplasty procedure preceding possible stent implantation.
• Patients who demonstrate evidence of a fusiform or saccular aneurysm of the vessel.

WARNINGS

• Care should be taken during stent deployment to avoid stent placement beyond the iliac ostium into the aorta as this may result in thrombus formation.
• A stent cannot be repositioned or removed after the deployment threshold has been exceeded.

PRECAUTIONS

• Stenting across a major bifurcation may result in stenosis or occlusion of the nonstented vascular limb, and prevent or hinder future access for angioplasty procedures.
• The safety and effectiveness of the WALLSTENT™ RP Endoprosthesis has not been established for use:
• at a lesion site within a vascular graft or at the anastomosis
• in patients for whom antiplatelet, anticoagulation therapy, or thrombolytic drugs are contraindicated or who exhibit coagulopathy
• in pediatric patients
• in total non-thrombotic chronic iliac artery occlusions

• Thrombosis
• Stent Misplacement
• Bleeding Requiring Transfusion
• Hematoma Requiring Repair
• Distal Emboli
• Pseudoaneurysm
• Minor Hematoma
• Intraluminal Thrombus
• Cerebrovascular Incident
• Death

Additional adverse events that have been reported to be associated with iliac stenting, although not observed in the clinical study include:

• Vessel Rupture
• Sepsis/Infection
• AV Fistula Formation
• Stent Migration
• Need for Bypass or Amputation
• Dissection