The number of evaluated valves were achieved.

The AndraValvulotome Post-Market Study is a prospective, open-label, multi-center study to evaluate the efficacy and safety of the AndraValvulotome. A maximum of 70 patients will be enrolled with peripheral artery disease (PAD) in up to 10 sites. Study participants will be primarily observed during the bypass procedure. In addition, the patients will be re-evaluated at the follow-up visit which will be scheduled 30 +/- 7 days after beginning of the study participation.

The objective of this study is to analyze the efficacy and safety of the valvulotomy of the venous valves with the CE marked AndraValvulotome during the bypass procedure.

Inclusion Criteria:

• Patients with peripheral arterial disease who are planned to undergo a bypass surgery with autologous vena saphena magna and using a valvulotome.
• Patient has to be consented and a informed consent form needs to be signed.
• Patient is able to and willing to participate in the 30 days follow-up.
• Vein diameter is at least 2mm (4F system) and 3mm (5F system).
• Vein diameter does not exceed 8mm (OTW-version) or 6mm (TIP-version)
• Bypass needs to be a continuous vena saphena magna with a length of at least 20cm.
• Rutherford category III - VI

Exclusion Criteria:

• Patients who have not completed 18 years of age
• Patients who are pregnant or assuming to be pregnant, and breast feeding.
• Patients who cannot participate due to medical or physical condition based on the decision of the physician.
• Life expectancy less than 1 year
• Known allergies to materials of the tip, cutting basket, outer catheter, kink protection and braid.
• Rutherford category 0-2
• Using varicose vein
• Exclusion criteria based on IFU