TADV Insights From ISET 2024: A Discussion With Dr. Anahita Dua

New technologies are changing the way CLTI patients are treated. Recently, Dr. Anahita Dua discussed the clinical outcomes from CLARITI and PROMISE II, and how the LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is changing the therapy options for patients who would otherwise need amputation. Listen as Dr. Dua shares her insights into clinical data, patient selection, and the importance of patient follow-up.

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 AR

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