Patient has a planned surgical or interventional procedure within 30 days after the study procedure.Patient has had a failed crossing attempt without an intervening intervention on the target limb within the past 14 days. material through various methods such as Diffusion Bonding / Cladding, Electron Beam Welding, Solder Reflow and Resistance Welding.Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.Patient has a known sensitivity or allergy to all anti-platelet medications.Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.Occlusion can be within previously implanted stent.1: Add SPX35090US ReFlow Medical Spex 35-Support Catheter-.035' x 90cm. Reconstitution of vessel at least 2cm above bifurcation/trifurcation. ReFlow Medical Wingman 18 Crossing Catheter-.018' x 135cm.018' x 135cm 50.00.Lesion cannot be crossed by concurrent conventional guidewire.

Patient has Rutherford Classification of 2-5.Target lesion(s) is ≥ 1 cm and Patient has at least one but not more than two occluded infrainguinal arteries that are 99-100% stenosed and no flow is observed in the distal lesion except the flow from collateral circulation.Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.Patient is willing and able to comply with the study protocol. Working with physicians to find solutions for unmet clinical needs, our team has produced innovative medical devices that are proven in practices every day.Patient is willing and able to provide informed consent.The FDA is classifying this as a Class 1 recall, the most serious recall situation. Why Should I Register and Submit Results? On April 22, 2017, ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters.

Reflow medical