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LimFlow System Intended Use/Indications for Use: The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation. Contraindications: Patients with deep venous thrombus in target vein; Patients with uncorrected bleeding disorders or patients who cannot receive anticoagulation or antiplatelet aggregation therapy Warnings and Precautions: Use in patients with concomitant hepatic insufficiency has not been evaluated; Use in patients with poor cardiac output, e.g., NYHA Class IV, has not been evaluated; Use in pregnant and breastfeeding women has not been evaluated; Implanting the device in the distal half of the calcaneus may result in stent fracture Adverse Events: Acute renal impairment requiring dialysis; Cardiac arrest; Death; Embolization; Graft rupture, trans-graft leak, site leak; Hematoma; Insufficient blood flow to foot; Ischemia; Myocardial infarction; Occlusion; Pain; Peripheral edema; Procedural bleeding; Restenosis of stented segment; Sepsis / Infection; Stent damage, implant migration; Stent graft fracture; Stent graft misplacement, deformation, or migration; The need for surgical or endovascular interventions to rectify an access site problem; Thrombosis; Vessel dissection, perforation, injury; Vessel spasm. Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events. LimFlow ARC Intended Use/Indications for Use: The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. LimFlow V-Ceiver Intended Use/Indications for Use: The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU. LimFlow Vector Intended Use/Indications for Use: The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves. Important Information: Prior to use, refer to the Instructions for Use for indications, contraindications, suggested procedure, warnings, adverse events, and precautions. Caution: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner.
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