Percutaneous Deep Vein Arterialization Post-Market Study
The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.
• Subject must be \> 21 and \< 95 years of age
• Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford category 5 or 6
• Assessment that no conventional surgical or endovascular treatment is possible
• Proximally, the target in-flow artery at the cross-over point must be treatable with a 3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be \<50% stenosed
• Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits