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US Device Guide / Mechanical Thrombectomy/Thrombolysis

Company Name Product Name Sheath Compatibility (F) Guidewire Compatibility (inch) Working Length (cm) Mode of Operation US FDA Indicated Use
Boston Scientific Corporation AngioJet Spiroflex Thrombectomy Set 5 0.014 135 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal Breaking apart and removing thrombus from coronary or saphenous vein graft lesions and infrainguinal peripheral arteries ≥ 2 mm in diameter
Boston Scientific Corporation AngioJet Spiroflex VG Thrombectomy Set 6 0.014 135 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal Breaking apart and removing thrombus from coronary or saphenous vein graft lesions and infrainguinal peripheral arteries ≥ 3 mm in diameter
Boston Scientific Corporation AngioJet XMI Thrombectomy Set 4 0.014 135 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal Breaking apart and removing thrombus from coronary or saphenous vein graft lesions and infrainguinal peripheral arteries ≥ 2 mm in diameter
Control Medical Technology Aspire Mechanical Thrombectomy Drive Unit Mechanical thrombectomy drive unit, continuous and/or pulsed mechanical thrombectomy High-performance thrombectomy pump and drive unit to improve thrombectomy performance
Thrombolex, Inc. Bashir Endovascular Catheter 7 0.018 92.5 Designed to rapidly restore blood flow with the attendant endogenous lytics upon manually expanding a 12.5-cm long infusion basket; physician-specified fluids, including thrombolytics, can be pulse-sprayed or infused through 48 precision-drilled holes in the basket into the thrombus; the basket is opened by an actuator on the handle, and infusion fluids can be administered via a syringe or infusion pump Indicated for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature
Thrombolex, Inc. Bashir N-X Endovascular Catheter 7 0.018 92.5 Designed to rapidly restore blood flow by pulse-spraying or infusing physician-specified fluids, including thrombolytics, into the target area via 48 precision-drilled holes; the infusion fluids are administered via a syringe or an infusion pump; may be used in the pulmonary arteries and peripheral vasculature; the patent center lumen of the device allows for pulmonary artery pressure measurements and mixed venous oxygen saturation during infusion Intended for the controlled and selective infusion of physician-specified fluids into the peripheral and pulmonary artery vasculature
Thrombolex, Inc. Bashir S-B Endovascular Catheter 7 0.018 92.5 Designed to rapidly restore blood flow with the attendant endogenous lytics upon manually expanding a 10-cm long infusion basket; physician-specified fluids, including thrombolytics, can be pulse-sprayed or infused through 48-precision drilled holes in the basket into the thrombus; the basket is opened by an actuator on the handle, and infusion fluids can be administered via a syringe or an infusion pump Intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature
Argon Medical Devices, Inc. Cleaner 15 7 65, 135 Battery-operated, handheld drive unit initiates the mechanical rotation of an atraumatic, wall-contacting, 15-mm sinusoidal cortex wire for effective thrombus maceration Indicated for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature; also indicated for mechanical declotting of native vessel dialysis fistulas and synthetic dialysis access grafts
Argon Medical Devices, Inc. Cleaner XT 6 65, 135 Battery-operated, handheld drive unit initiates the mechanical rotation of an atraumatic, wall-contacting, 9-mm sinusoidal vortex wire for effective thrombus maceration Indicated for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature; also indicated for mechanical declotting of native vessel dialysis fistulas and synthetic dialysis access grafts
Boston Scientific Corporation EkoSonic Endovascular System 6 0.035 106 (treatment areas: 6, 12, 18, 24, 30, 40, 50), 135 (treatment areas: 12, 30, 40, 50) The treatment offers a minimally invasive system for the acceleration of thrombus dissolution; the ultrasonic core generates a localized acoustic field that targets the entire thrombus; this greatly accelerates lytic dispersion by driving the drug deeper into the clot and unwinding the fibrin to expose plasminogen receptor sites Indicated for the ultrasound-facilitated, controlled, and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism; the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature; and the infusion of solutions into the pulmonary arteries; instructions for use, including warnings, precautions, potential complications, and contraindications can be found at www.btg-im.com/ekos; Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician
Penumbra, Inc. (Peripheral Vascular) Indigo System Catheter CAT RX 6 (guide catheter) 0.014 140 Mechanical thrombectomy Indicated for the removal of fresh, soft, emboli and thrombi from the vessels in the coronary and peripheral vasculature
Penumbra, Inc. (Peripheral Vascular) Indigo System Separator SEPC4 200 Separator-assisted clot debulking, if needed Indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature; part of the Indigo Aspiration System

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