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.