LimFlow® TADV System*
Transcatheter Arterialization of the Deep Veins (TADV) system for the treatment of chronic limb-threatening ischemia (CLTI)
Overview
Purpose-built innovation
for limb salvage
The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is a minimally invasive technology designed for patients with chronic limb-threatening ischemia (CLTI) who have no suitable conventional arterial revascularization options and are at risk for major amputation.
LimFlow is designed to restore blood flow to the ischemic foot by diverting blood around diseased arteries and into the tibial veins, bringing oxygenated blood to tissues deprived of adequate perfusion. By restoring blood flow, TADV is designed to promote wound healing, relieve ischemic pain and help patients avoid major amputation — with the goal of preserving the limb and improving quality of life.
System components
LimFlow ARC® (Arterial Catheter) and LimFlow V-Ceiver® (Venous Catheter)
The proprietary ARC (arterial catheter) and V-Ceiver (venous catheter) enable optimal visual alignment under fluoroscopy and provide a dependable solution in the setting of below-the-knee artery to vein crossing.
The V-Ceiver’s radiopaque mesh fills the vein to provide a distinct visual target and the ARC’s embedded crossing needle has a long reach to allow for multiple crossing options.
LimFlow Vector® (Valvulotome)
The LimFlow Vector's cutting basket with forward-facing hooks is designed to preserve the venous walls of the foot and avoid vessel trauma by obviating the need for high-pressure ballooning to improve outflow.
LimFlow Extension Stents
The novel electrospun PTFE-covered nitinol Extension Stents are designed to extend down the leg to the ankle region to enable blood flow to the lower limb.
LimFlow Crossing Stents
The LimFlow Crossing Stent is a distinct nitinol stent designed to cross between the artery to vein and offers precise deployment with the delivery system.
Clinical evidence
PROMISE I – U.S. Feasibility Study
PROMISE I is a multi-center, prospective, single-arm study conducted at seven U.S. centers encompassing end-stage — or “no option” — CLTI patients.
PROMISE II – U.S. Pivotal Study
PROMISE II is a landmark multi-center, prospective pivotal study of the LimFlow System conducted at 20 U.S. centers in 105 No-option CLTI patients typically excluded from other clinical studies.
PROMISE III Trial
PROMISE III is a prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System for the treatment of late-stage CLTI.
Contact
Contact
Connect with an expert
Thank you!
Follow us on social media
Engage with us on social media to find information about upcoming MedEd events, including webinars, and to be among the first to receive news on technology enhancements, new clinical data and more.
*LimFlow TADV System includes the LimFlow System or LimFlow Stent Grafts, and LimFlow ARC, LimFlow Vector, and LimFlow V-Ceiver. Please refer to the ISI for more information.
Important Safety Information
Indications for Use
The LimFlow System and LimFlow Stent Grafts are 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 the target vein; patients with uncorrected bleeding disorders or 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 or 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; need for surgical or endovascular intervention to rectify an access site problem; thrombosis; vessel dissection, perforation or injury; vessel spasm. Review complete Instructions for Use, Indications for Use, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of these products.
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. The LimFlow ARC is not intended for use in the coronary or cerebral 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.
For all non-Stryker products, please review manufacturer complete Instructions for Use, Indications for Use, Warnings, Precautions, Possible Adverse Effects and Contraindications.
Caution
Federal (USA) law restricts these devices to sale by or on the order of a physician.
All trademarks are property of their respective owners.
PRO-4505-USA-EN-v1