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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
Penumbra, Inc. (Neuro) 3D Revascularization Device 6 (long sheath [Neuron MAX]) 0.020 200 (delivery wire; compatible with Velocity Delivery microcatheter [160 cm] and 3MAX Reperfusion catheter [160 cm]) Designed for use in combination with ACE Reperfusion catheters; the architecture enables maximum clot capture capability through four intraluminal chambers and is optimized for use with aspiration delivered by ACE catheters or the Penumbra JET 7 Reperfusion catheter Part of the Penumbra System; indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral–M1 and M2 segments) within 8 hours of symptom onset; patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment
Boston Scientific Corporation AngioJet AVX Thrombectomy Catheter 6 0.035 50 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal Breaking apart and removing thrombus from AV access conduits ≥ 3 mm in diameter
Boston Scientific Corporation AngioJet PE Thrombectomy Catheter 6 0.035 120 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal Breaking apart and removing thrombus from upper and lower extremity peripheral veins, iliofemoral and lower extremity peripheral veins ≥ 6 mm in diameter, and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system
Boston Scientific Corporation AngioJet Solent Dista Thrombectomy Catheter 4 0.014 145 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal Breaking apart and removing thrombus from upper and lower extremity peripheral arteries ≥ 1.5 mm in diameter and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system
Boston Scientific Corporation AngioJet Solent Omni Thrombectomy Catheter 6 0.035 120 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal Breaking apart and removing thrombus from upper and lower extremity peripheral arteries, upper extremity peripheral veins, iliofemoral and lower extremity peripheral veins ≥ 3 mm in diameter, and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system
Boston Scientific Corporation AngioJet Solent Proxi Thrombectomy Catheter 6 0.035 90 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal Breaking apart and removing thrombus from upper and lower extremity peripheral arteries, upper extremity peripheral veins, iliofemoral and lower extremity peripheral veins ≥ 3 mm in diameter, and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system
Boston Scientific Corporation AngioJet Solent ZelanteDVT Thrombectomy Catheter 8 0.035 105 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal Breaking apart and removing thrombus from upper and lower extremity peripheral veins, iliofemoral and lower extremity peripheral veins ≥ 6 mm in diameter, and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system
Teleflex Arrow-Trerotola OTW PTD 7 0.025 65, 120 Battery-operated handheld unit rotates unique 9-mm fragmentation basket at 3,000 rpm, macerating clot to < 2 mm; basket can be deployed/withdrawn within catheter; deployed basket can be used to pull arterial plug Permits mechanical declotting of native arterio/venous fistula synthetic dialysis grafts in conjunction with the Arrow Rotator Drive Unit (PT-03000-R)
Teleflex Arrow-Trerotola PTD 5 65 Battery-operated handheld unit rotates unique 9-mm fragmentation basket at 3,000 rpm, macerating clot to < 2 mm; basket can be deployed/withdrawn within the catheter; deployed basket can be used to pull arterial plug Permits mechanical declotting of native arterio/venous fistula and synthetic dialysis grafts in conjunction with the Arrow Rotator Drive Unit (PT-03000-R)
Control Medical Technology Aspire Mechanical Thrombectomy Drive Unit Mechanical thrombectomy drive unit, continuous and/or pulsed mechanical thrombectomy A 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 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 Endvascular 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 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 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
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
Inari Medical ClotTriever Thrombectomy System 13 0.018, 0.035 74 Mechanical coring, collection, and retrieval of emboli and thrombi The nonsurgical removal of soft emboli and thrombi from blood vessels; injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel; intended for use in the peripheral vasculature
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
Inari Medical FlowTriever Retrieval/Aspiration System 20 0.035 95 Mechanical and aspirational disruption, fragmentation, maceration, and retrieval of emboli and thrombi The nonsurgical removal of emboli and thrombi from blood vessels; injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel; intended for use in the peripheral vasculature and for the treatment of pulmonary embolism
ICHOR Vascular ICHOR Aceso 12 12 0.035 45, 90, 150 Disobliteration using a compliant balloon as the primary mechanism of action with supportive aspiration to sweep thrombus, acute clot, or embolic material into the extraction funnel; the "control sheath" has an occlusion balloon to manage flow, maximize clot removal, while reducing distal embolization Indicated for the nonsurgical removal of emboli and thrombi from blood vessels; intended for the peripheral vasculature, and is not intended for use in the coronary or neurovasculature
ICHOR Vascular ICHOR Panacea 7 7 0.014 45, 90, 150 Disobliteration using a compliant balloon as the primary mechanism of action with supportive aspiration to sweep thrombus, acute clot, or embolic material into the extraction funnel; the "control sheath" has an occlusion balloon to manage flow, maximize clot removal, while reducing distal embolization Indicated for the nonsurgical removal of emboli and thrombi from blood vessels; intended for the peripheral vasculature, and is not intended for use in the coronary or neurovasculature
Penumbra, Inc. (Peripheral Vascular) Indigo System Catheters: CAT8, CATD, CAT6, CAT5, CAT3, and CAT RX 8 (CATD, CAT8), 6 (CAT6, CAT5), 5 (CAT3), 6-F guide catheter (CAT RX) 0.014–0.038 50–150 Separator-assisted mechanical extraction of thrombus/embolus with constant vacuum aspiration; available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee Indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems; as part of the Indigo Aspiration System, the Indigo CAT RX aspiration catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature
Penumbra, Inc. (Peripheral Vascular) Indigo System Separators: SEP8, SEPD, SEP6, SEP5, SEP3, SEPC4 90–200 The device is advanced and retracted through the CAT catheter at the proximal margin of the primary occlusion to facilitate the clearing of the thrombus from the catheter tip, as needed Indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems; as part of the Indigo Aspiration System, the Indigo CAT RX aspiration catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature
Walk Vascular, LLC Jeti–6 Fr 6 0.010–0.038 (OTW) or none 120 Internal saline jet just within the catheter tip breaks up thrombus and soft emboli while removing the thrombus through aspiration For all peripheral venous and arterial vasculature
Walk Vascular, LLC Jeti–8 Fr 8 0.010–0.038 (OTW) or none 100 Internal saline jet just within the catheter tip breaks up thrombus and soft emboli while removing the thrombus through aspiration For all peripheral venous and arterial vasculature
Penumbra, Inc. (Neuro) Penumbra System Reperfusion Catheters: Penumbra JET 7, Penumbra JET D, ACE, 5MAX, 4MAX, 3MAX, and 026 6 (Penumbra JET 7, Penumbra JET D, ACE, and 5MAX require 8-F short sheath or 6-F long sheath) 0.014–0.016 132–160 Direct aspiration clot removal with Penumbra Engine aspiration source As part of the Penumbra System, the Reperfusion catheters and separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral— M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment
Penumbra, Inc. (Neuro) Penumbra System Separator and Separator Flex: 5MAX, 4MAX, 3MAX, and 026 175–200 (Separator and Separator Flex length) Separator-assisted clot debulking, if needed As part of the Penumbra System, the Reperfusion catheters and separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral—M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset; patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment
Codman Neuro (Johnson & Johnson) Revive PV Peripheral Vascular Thrombectomy Device 5 or larger 205 Mechanical thrombectomy with aspiration The nonsurgical removal of emboli and thrombi from peripheral blood vessels
Medtronic Solitaire Platinum Revascularization Device 4 X 20, 4 X 40, 6 X 20 8, 9 (balloon guide) 0.014 180 (Solitaire push wire) Designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion and for use in the neurovasculature, such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries Indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received IV tPA; endovascular therapy with the device should be started within 6 hours of symptom onset; indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset; patients who are ineligible for IV tPA or who fail IV tPA therapy are candidates for treatment
Medtronic Solitaire X Revascularization Device (4 X 20; 4 X 40; 6 X 20; 6 X 24; 6 X 40 mm) 0.021 200 1) Indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA)—endovascular therapy with the device should be started within 6 hours of symptom onset; 2) indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset—patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment; 3) indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (< 70 cc by CTA or MRA; < 25 cc by MR-DWI)—endovascular therapy with the device should start within 6–16 hours of time last seen well in patients who are ineligible forIV t-PA or who fail IV t-PA therapy
Medtronic Solitaire X-Pack (2 pack: 4 X 40 or 6 X 40 mm with Phenom 21 or 27) 200 1) Indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA)—endovascular therapy with the device should be started within 6 hours of symptom onset; 2) indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset—patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment; 3) indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (< 70 cc by CTA or MRA; < 25 cc by MR-DWI)—endovascular therapy with the device should start within 6–16 hours of time last seen well in patients who are ineligible forIV t-PA or who fail IV t-PA therapy
Medtronic Solitaire X-Pack (3 pack: 4 X 40 or 6 X 40 mm with Phenom 21 or 27 or React 68 or 71) 200 1) Indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA)—endovascular therapy with the device should be started within 6 hours of symptom onset; 2) indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset—patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment; 3) indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (< 70 cc by CTA or MRA; < 25 cc by MR-DWI)—endovascular therapy with the device should start within 6–16 hours of time last seen well in patients who are ineligible forIV t-PA or who fail IV t-PA therapy
Stryker Trevo XP ProVue Retriever; 3 X 20 mm, 4 X 20 mm, 4 X 30 mm, 6 X 25 mm 8, 9 (balloon guide catheter) 0.014 190 for 3 X 20 mm, 180 for 4 X 20 mm, 4 X 30 mm, and 6 X 25 mm Mechanical thrombectomy; 360° of consistently large cells, a soft distal tip and full-length radiopacity Indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large-vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA); endovascular therapy with the device should start within 6 hours of symptom onset Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset; patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment Indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large-vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller-core infarcts (0–50 cc for age < 80 years, 0–20 cc for age ≥ 80 years); endovascular therapy with the device should start within 6–24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy

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