Instructions for Use
In accordance with the FDA Medical Device Regulation, LimFlow is providing the following instructions for use (IFUs) to inform physicians, hospital, and payors of the intended purpose, proper use, and any precautions to be taken when using the LimFlow System for Transcatheter Arterialization of Deep Veins (TADV).
U.S. Instructions for Use
LimFlow ARC® Instructions for Use
LimFlow V-Ceiver® Instructions for Use
LimFlow Vector® Instructions for Use
LimFlow® System Instructions for Use
Brief Statement
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