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According to the applicant, the DETOUR System received Breakthrough Device designation from FDA on September 2, 2020 for percutaneous revascularization of symptomatic femoropopliteal lesions 200mm to 460mm with a chronic total occlusion 100mm to 425mm, and/or moderate-to-severe calcification, and/or in-stent-restenosis in patients with severe peripheral arterial disease

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Patients who arrive after self-administering research-grade peptides with inconsistent results are often experiencing the consequence of dosing with a product whose actual potency and sterility were never verified