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EUROPEAN Device Guide / Mechanical Thrombectomy/Thrombolysis

Company Name Product Name Sheath Compatibility (F) Guidewire Compatibility (inch) Working Length (cm) Mode of Operation CE Mark Indications
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 [153 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 reperfusion catheters or Penumbra JET 7 As part of the Penumbra System, the Penumbra 3D Revascularization Device is 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 Set 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 Distaflex Thrombectomy Set 4 0.014 145 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions prior to balloon angioplasty or stent placement and use in breaking apart and removing thrombus from infrainguinal peripheral arteries ≥ 2 mm in diameter
Boston Scientific Corporation AngioJet Solent Dista Thrombectomy Set 4 0.014 145 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal (PowerPulse enabled) Breaking apart and removing thrombus from upper and lower extremity peripheral arteries ≥ 1.5 mm in diameter
Boston Scientific Corporation AngioJet Solent Omni Thrombectomy Set 6 0.035 120 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal (PowerPulse enabled) Breaking apart and removing thrombus from upper and lower extremity peripheral arteries, upper extremity peripheral veins, iliofemoral and lower extremity veins, and AV access conduits ≥ 3 mm in diameter
Boston Scientific Corporation AngioJet Solent Proxi Thrombectomy Set 6 0.035 90 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal (PowerPulse enabled) Breaking apart and removing thrombus from upper and lower extremity peripheral arteries, upper extremity peripheral veins, iliofemoral and lower extremity veins, and AV access conduits ≥ 3 mm in diameter
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 Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions prior to balloon angioplasty or stent placement and use in breaking apart and removing thrombus from infrainguinal peripheral arteries ≥ 2 mm in diameter
Boston Scientific Corporation AngioJet SpiroflexVG Thrombectomy Set 6 0.014 135 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions prior to balloon angioplasty or stent placement and use in breaking apart and removing thrombus from infrainguinal peripheral arteries ≥ 3 mm in diameter
Boston Scientific Corporation AngioJet Ultra PE Thrombectomy Set 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 main pulmonary and lobar arteries ≥ 6 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 Removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions prior to balloon angioplasty or stent placement and use in breaking apart and removing thrombus from infrainguinal peripheral arteries ≥ 2 mm in diameter
Boston Scientific Corporation AngioJet ZelanteDVT Thrombectomy Set 8 0.035 105 High-velocity water jets enclosed in catheter utilize the Bernoulli principle for capture, microfragmentation, and removal (PowerPulse enabled) Intended for use with the AngioJetUltra Console to break apart and remove thrombus, including DVT, from: Iliofemoral and lower extremity veins ≥ 6 mm in diameter and upper extremity peripheral veins ≥ 6 mm in diameter; also intended for use with the AngioJet Ultra Power Pulse technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system
Acandis GmbH & Co. KG Aperio 1.9 F Thrombectomy Device 0.010–0.014 30 mm Thrombectomy device for the mechanical extraction of clots from cerebral vessels with a diameter > 2 and ≤ 4 mm Intended for use of restoration of the arterial flow for patients diagnosed with ischemic stroke due to large intracranial vessel occlusion (ie, internal carotid artery, M1 and M2 segments of the MCA); patients who fail intravenous thrombolytic therapy or who are ineligible for thrombolysis may be suited for treatment with the Aperio device
Acandis GmbH & Co. KG Aperio 3 F Thrombectomy System 0.010–0.014 40 mm Thrombectomy system (includes microcatheter) for the mechanical extraction of clots from cerebral vessels with a diameter > 2 and ≤ 4 mm Intended for use of restoration of the arterial flow for patients diagnosed with ischemic stroke due to large intracranial vessel occlusion (ie, internal carotid artery, M1 and M2 segments of the MCA); patients who fail intravenous thrombolytic therapy or who are ineligible for thrombolysis may be suited for treatment with the Aperio device
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 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)
Control Medical Technology Aspire Aspirator Mechanical aspirator High-performance aspiration pump and drive unit to improve aspiration performance
Straub Medical AG Aspirex S 6 0.018 110, 135 Aspirex S catheters in combination with the Straub Medical Drive System (REF SRS-Set/80300) are intended for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from blood vessels outside the cardiopulmonary, coronary, and cerebral circulations Native blood vessels or vessels fitted with stents, stent grafts, or native or artificial bypasses outside the cardiopulmonary, coronary, and cerebral circulations
Straub Medical AG Aspirex S 8 0.018 85, 110 Aspirex S catheters in combination with the Straub Medical Drive System (REF SRS-Set/80300) are intended for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from blood vessels outside the cardiopulmonary, coronary, and cerebral circulations Native blood vessels or vessels fitted with stents, stent grafts, or native or artificial bypasses outside the cardiopulmonary, coronary, and cerebral circulations
Straub Medical AG Aspirex S 10 0.025 110 Aspirex S catheters in combination with the Straub Medical Drive System (REF SRS-Set/80300) are intended for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from blood vessels outside the cardiopulmonary, coronary, and cerebral circulations Native blood vessels or vessels fitted with stents, stent grafts, or native or artificial bypasses outside the cardiopulmonary, coronary, and cerebral circulations
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
Boston Scientific Corporation EkoSonic Endovascular System 6 0.035 106 catheter length (treatment areas: 6, 12, 18, 24, 30, 40, 50), 135 catheter length (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 Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature; for the treatment of pulmonary embolism with a ≥ 50% clot burden in one or both main pulmonary arteries or lobar pulmonary arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure ≥ 25 mm Hg) or echocardiographic evaluation
MicroVention Terumo Eric Retrieval Device 0.017- and 0.021-inch microcatheter 0.014 15, 20, 24, 30, 35, 44 Clot retriever device with intraluminal clot capture surface The Eric retrieval device is intended for use in the revascularization of acute ischemic stroke caused by the intracranial occlusive vessels of patients who are not eligible for intravenous tissue plasminogen activator (IV tPA) or who fail IV tPA therapy
Penumbra, Inc. (Peripheral Vascular) Indigo System Catheter CAT8, CATD, CAT6, CAT5, and CAT3 8 (CAT8, CATD) 6 (CAT6, CAT5) 5 (CAT3) 0.014–0.038 50–150 Separator-assisted mechanical extraction of thrombus/embolus with constant vacuum aspiration The Indigo Aspiration catheters and separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems
Penumbra, Inc. (Peripheral Vascular) Indigo System Separator SEP8, SEPD, SEP6, SEP5, and SEP3 90–190 Separator-assisted mechanical extraction of thrombus/embolus with constant vacuum aspiration The Indigo Aspiration catheters and separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems
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
Invamed Mantis 7 90 Battery-operated, handheld drive unit initiates the mechanical rotation of an atraumatic unique loop shape with aspiration DVT pharmacomechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature; double engine volume, low and high speed options; hydrophilic tip
Vesalio NeVa M1 - Vesalio NeVa Mechanical Thrombectomy System 30 mm (retriever length) Only thrombectomy device with drop zones for clot retrieval in AIS; indicated for vessels with diameter > 2 and ≤ 3.5 mm; maximal diameter: 4 mm; microcatheter compatibility: 0.021-inch ID Indicated for temporary use to restore blood flow in the cerebral vasculature of patients suffering from an acute ischemic stroke; the Vesalio NeVa mechanical thrombectomy system is positioned across the embolus or blood clot and is used to facilitate the restoration of blood flow and removal of the clot obstruction; indicated for endovascular temporary use in patients with acute ischemic stroke and to restore blood flow in patients with symptoms of an acute ischemic stroke caused by an embolus in a cerebral vessel
Vesalio NeVa M1S - Vesalio NeVa Mechanical Thrombectomy System 22 mm (retriever length) Only thrombectomy device with drop zones for clot retrieval in AIS; indicated for vessels with diameter > 2 mm and ≤ 3.5 mm; maximal diameter: 4.0 mm; microcatheter compatibility: 0.021-inch ID Indicated for temporary use to restore blood flow in the cerebral vasculature of patients suffering from an acute ischemic stroke; the Vesalio NeVa mechanical thrombectomy system is positioned across the embolus or blood clot and is used to facilitate restoration of blood flow and removal of clot obstruction; indicated for endovascular temporary use in patients with acute ischemic stroke and to restore blood flow in patients with symptoms of an acute ischemic stroke caused by an embolus in a cerebral vessel
Vesalio NeVa T - Vesalio NeVa Mechanical Thrombectomy System 37 mm (retriever length) Only thrombectomy device with drop zones for clot retrieval in AIS; indicated for vessels with diameter > 2 mm and ≤ 4.5 mm; maximal diameter: 4.5 mm; microcatheter compatibility: 0.021-inch ID Indicated for temporary use to restore blood flow in the cerebral vasculature of patients suffering from an acute ischemic stroke; the Vesalio NeVa mechanical thrombectomy system is positioned across the embolus or blood clot and is used to facilitate the restoration of blood flow and removal of the clot obstruction; indicated for endovascular temporary use in patients with acute ischemic stroke and to restore blood flow in patients with symptoms of an acute ischemic stroke caused by an embolus in a cerebral vessel
Penumbra, Inc. (Neuro) Penumbra System Reperfusion Catheter JET 7, JET D, ACE, 5MAX, 4MAX, 3MAX, 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 and 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
Penumbra, Inc. (Neuro) Penumbra System Separator and Separator Flex 5MAX, 4MAX, 3MAX, 026 Separator and separator flex length: 175–200 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
phenox GmbH Preset Lite Thrombectomy Device 0.0165 inch (ID) 180 (insertion wire) Introduced into the target vessel through a suitable microcatheter and deployed inside the thrombus or distal to the thrombus; after complete deployment the slow withdrawal of the instrument occurs under continuous aspiration via the guiding catheter or aspiration catheter Designed for mechanical clot retrieval from intracranial arteries as acute ischemic stroke treatment for patients who are ineligible for intravenous thrombolysis or for patients who failed thrombolysis therapy and as a supplement treatment of an initiated thrombolysis therapy
phenox GmbH Preset Thrombectomy Device 0.021 inch (ID) 180 (insertion wire) Introduced into the target vessel through a suitable microcatheter and deployed inside the thrombus or distal to the thrombus; after complete deployment the slow withdrawal of the instrument occurs under continuous aspiration via the guiding catheter or aspiration catheter Designed for mechanical clot retrieval from intracranial arteries as acute ischemic stroke treatment for patients who are ineligible for intravenous thrombolysis or for patients who failed thrombolysis therapy and as a supplement treatment of an initiated thrombolysis therapy
Codman Neuro (Johnson & Johnson) ReVive SE Thrombectomy Device 5 or larger 205 Mechanical thrombectomy (stent retriever) Indicated to restore blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease by providing temporary bypass across the occlusion and/or by the nonsurgical removal of emboli and thrombi; it may be used with aspiration and with the injection or infusion of contrast media and other fluids; the close-ended basket captures clots and large fragments
MicroVention Terumo Sofia Plus Aspiration Catheter 6 125, 131 Aspiration catheter Indicated for general intravascular use, including the peripheral and neurovasculatures; can be used to facilitate introduction of diagnostic or therapeutic agents; not intended for use in coronary arteries; intended for use in the removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the peripheral and neurovasculatures
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; 360º 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
Invamed Viper 5 0.035 200 Designed for controlled infusion of tPA along with mechanical vibrations Over the guidewire system and 200 cm catheter length allows safe access to closed target vessels including pulmonary artery in PE cases

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