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UNI-FUSE INFUSION SYSTEM INDICATIONS FOR USE: The UNI*FUSE Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature. Contraindications: The UNI*FUSE Infusion System is contraindicated for use in the coronary and cerebral vasculature. The UNI*FUSE Infusion System is not intended for the infusion of blood or blood products. Refer to the product insert of the therapeutic solution for indications, contraindications, side effects, cautions and warnings. Warnings: • Single patient use. Do not re-use or resterilize. • Do not use if package is damaged. • This product should be used only by physicians who have a thorough understanding of angiography and percutaneous interventional procedures. • Do not inject contrast medium with a pressure injector if the occluding ball wire is in place. • Use an introducer sheath if the puncture is through a synthetic graft. • Failure to use an introducer sheath may result in damage to the catheter or occluding ball wire. • Reprocessing may compromise the integrity of the device and/or lead to device failures. • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient. • Complications may occur, if all the air has not been removed from the infusion catheter and displaced with saline prior to insertion into the body. • Never advance the guidewire against resistance; this could cause vessel trauma and/or wire damage. Determine the cause of resistance under fluoroscopy and take any necessary remedial action. Potential Complications: Potential Complications include, but are not limited to Hematoma at the entry site, Vessel perforation, Vasospasm, Hemorrhage, Contrast extravasation, Embolism, Drug reaction, Allergic reaction to contrast media, Neurological deficits including stroke and death, Pain and tenderness, Vessel dissection, Vascular thrombosis, Other - case (or patient) to which the therapeutic solution is inadequate. THE ANGIOVAC CANNULA C20 AND C180 (GENERATION 3) INDICATIONS FOR USE: The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours. Contraindications: The Following contraindications are applicable: • Do not use if the patient has severe arterial or venous vascular disease. • The device is contraindicated in the removal of chronic firmly adherent intravascular material (e.g., atherosclerotic plaque, chronic pulmonary embolism). • The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation. Warnings: • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping. • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred. Failure to inspect could result in injury to patient or user. • Verify that the lumen is patent and that the cannula has not been damaged or kinked prior to use. • Instructions for use and manuals for the AngioVac Cannula and all related accessories and extracorporeal circulatory devices should be read prior to use and devices used as indicated. • Selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians’ sole responsibility. The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique. The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician. • As with all medical devices, this device and ancillary equipment are to be used by trained physicians only. Specifically, this device is to be used only by medical personnel experienced with initiating and monitoring extracorporeal bypass and by physicians trained and experienced using surgical and/or percutaneous (Seldinger) vascular access techniques. • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device. • Do not use in conjunction with a power injector. • Do not alter the AngioVac Cannula in any way. Adverse Events: This device, as do all extracorporeal blood vessel devices, has possible side effects, which include but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques. These may occur if the instructions for use are not followed. Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited to: • Air Embolism • Arrhythmias • Blood Loss/Blood Trauma • Death • Damage to Vessel • Device Fracture • Distal Embolization of Thrombus • Hematoma • Hemoptysis • Hemorrhage • Local or Systemic Infections • Pleural Effusion • Pulmonary Embolism • Pulmonary Infarction • Vascular Thrombosis • Venous Valve Injury • Ventricular Perforation • Vessel Spasm THE ANGIOVAC CIRCUIT INDICATIONS FOR USE: AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours. Contraindications: Refer to the AngioVac Cannula Directions for Use (DFU) for procedure-specific contraindications. Warnings: • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping. • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred. Failure to inspect could result in injury to patient or user. • Carefully examine the circuit for leaks before and during use. Leakage may result in loss of sterility, blood loss or air embolism. If leakage is observed replace the circuit, the leaking component or tighten the leaking connection. • Instructions for use and manuals for all related extracorporeal circulatory devices should be read prior to use, including but not limited to the AngioVac Cannula, centrifugal pump head, control console and bubble trap. • As with all medical devices, this device is to be used by or under the direction of trained physicians only. • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device. Adverse Events: Possible complications include those normally associated with anticoagulation and extracorporeal circulation. This product, as with all extracorporeal circulatory systems, has possible side effects, which include but are not limited to infections, blood loss/blood trauma, thrombus formation and embolic events. These may occur if the instructions for use are not followed. Refer to AngioVac Cannula DFU for additional listing of potential adverse events. Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product. ANGIOVAC CANNULA (GENERATION 2) INDICATIONS FOR USE: The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours. Contraindications: • Do not use if the patient has severe arterial or venous vascular disease. • The device is contraindicated in the removal of chronic firmly adherent intravascular material (e.g., atherosclerotic plaque, chronic pulmonary embolism). • The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation. Warnings: • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping. • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred. Failure to inspect could result in injury to patient or user. • Verify that the lumen is patent and that the cannula has not been damaged or kinked prior to use. • Instructions for use and manuals for the AngioVac Cannula and all related accessories and extracorporeal circulatory devices should be read prior to use and devices used as indicated. • Selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians’ sole responsibility. The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique. The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician. • As with all medical devices, this device and ancillary equipment are to be used by trained physicians only. Specifically, this device is to be used only by medical personnel experienced with initiating and monitoring extracorporeal bypass and by physicians trained and experienced using surgical and/or percutaneous (Seldinger) vascular access techniques. • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device. • Do not use in conjunction with a power injector. • Do not alter the AngioVac Cannula in any way. Adverse Events: This device, as do all extracorporeal blood vessel devices, has possible side effects, which include but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques. These may occur if the instructions for use are not followed. Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited to: • Air Embolism • Arrhythmias • Blood Loss/Blood Trauma • Death • Damage to Vessel • Device Fracture/Balloon Rupture with Distal Embolization • Distal Embolization of Thrombus • Hematoma • Hemoptysis • Hemorrhage • Local or Systemic Infections • Pleural Effusion • Pulmonary Embolism • Pulmonary Infarction • Vascular Thrombus • Venous Valve Injury • Ventricular Perforation • Vessel Spasm Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. *AngioDynamics, the AngioDynamics logo, AngioVac, the AngioVac logo, Uni-Fuse, and the Uni-Fuse logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate, or a subsidiary. © 2020 AngioDynamics, Inc. US/VI/TS/464 Rev 01 10/2020
Risk Information & Trademarks
A NEW ANGLE ON PATIENT CARE
FEATURES & BENEFITS
180 ANGLED TIP
C180
20 ANGLED TIP
C20
OR
Available Tip Shapes
Self-expanding funnel shaped, actuated tip using slide over sheath
Radiopaque nitinol tip allows for visualization under fluoroscopic imaging
Proximal locking touhy to maintain desired cannula angle
Hydrophilic coating on the obturator allows for easier insertion through the Y-Adapter and AngioVac Cannula
Cannula shaft supported by a flat stainless steel coiled wire within the catheter body to support greater pushability, kink resistance, column strength
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THE ANGIOVAC SYSTEM CAN BE USED IN THE...
Anatomical placement
rIGHT aTRIUM rIGHT vENTRICLE
sUPERIOR vENA cAVA INFERIOR VENA CAVA ILIOFEMORAL VEINS
THE ANGIOVAC SYSTEM: GENERATION 3
Self-Expanding Nitinol Reinforced Funnel Tip The AngioVac Cannula Inner Diameter: 20.2F (6.73mm) The AngioVac Cannula Outer Diameter: 23F (7.56mm) 180 Degree Angle and 20 Degree Angle Flat Stainless Steel Wire Extruded in Wall
THE ANGIOVAC SYSTEM: GENERATION 2
Balloon Actuated Funnel Tip The AngioVac Cannula Inner Diameter: 19F (6.33mm) The AngioVac Cannula Outer Diameter: 26F (8.67mm) Straight and 20 Degree Angle Round Stainless Steel Wire Extruded in Cannula Wall
how are they different?
Risk Information
AngioDynamics, the AngioDynamics logo, AngioVac and the AngioVac logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate, or a subsidiary.
Indication for Use: The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours. Contraindications: The Following contraindications are applicable: • Do not use if the patient has severe arterial or venous vascular disease. • The device is contraindicated in the removal of chronic firmly adherent intravascular material (e.g., atherosclerotic plaque, chronic pulmonary embolism). • The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation. Warnings: • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping. • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred. Failure to inspect could result in injury to patient or user. • Verify that the lumen is patent and that the cannula has not been damaged or kinked prior to use. • Instructions for use and manuals for the AngioVac Cannula and all related accessories and extracorporeal circulatory devices should be read prior to use and devices used as indicated. • Selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians’ sole responsibility. The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique. The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician. • As with all medical devices, this device and ancillary equipment are to be used by trained physicians only. Specifically, this device is to be used only by medical personnel experienced with initiating and monitoring extracorporeal bypass and by physicians trained and experienced using surgical and/or percutaneous (Seldinger) vascular access techniques. • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device. • Do not use in conjunction with a power injector. • Do not alter the AngioVac Cannula in any way. Adverse Events: This device, as do all extracorporeal blood vessel devices, has possible side effects, which include but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques. These may occur if the instructions for use are not followed. Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited to: • Air Embolism • Arrhythmias • Blood Loss/Blood Trauma • Death • Damage to Vessel • Device Fracture • Distal Embolization of Thrombus • Hematoma • Hemoptysis • Hemorrhage • Local or Systemic Infections • Pleural Effusion • Pulmonary Embolism • Pulmonary Infarction • Vascular Thrombosis • Venous Valve Injury • Ventricular Perforation • Vessel Spasm Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Indication for Use: AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours. Contraindications: Refer to the AngioVac Cannula Directions for Use (DFU) for procedure-specific contraindications. Warnings: • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping. • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred. Failure to inspect could result in injury to patient or user. • Carefully examine the circuit for leaks before and during use. Leakage may result in loss of sterility, blood loss or air embolism. If leakage is observed replace the circuit, the leaking component or tighten the leaking connection. • Instructions for use and manuals for all related extracorporeal circulatory devices should be read prior to use, including but not limited to the AngioVac Cannula, centrifugal pump head, control console and bubble trap. • As with all medical devices, this device is to be used by or under the direction of trained physicians only. • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device. Adverse Events: Possible complications include those normally associated with anticoagulation and extracorporeal circulation. This product, as with all extracorporeal circulatory systems, has possible side effects, which include but are not limited to infections, blood loss/blood trauma, thrombus formation and embolic events. These may occur if the instructions for use are not followed. Refer to AngioVac Cannula DFU for additional listing of potential adverse events. Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
ANGM 1208 GL Rev 01 10/19
2020, AngioDynamics, Inc.
01
/ 05
Case Information
Physicians: Dr. Zlotnick* (IC) & Dr. Aldridge (CT) Hospital: Buffalo General Location: Buffalo, NY Device Type: Second Generation of the AngioVac System
†This case study represents the experience of one institution and is not indicative of all procedure results.
02
Disease State
The global incidence of cardiac implantable electronic device (CIED) infection is now increasing out of proportion to the rate of device implantation
1
2
3
4
CIED infections typically require complete device and lead removal
Large vegetations on the leads can dislodge and block the main pulmonary artery or one of its branches, causing hemodynamic collapse
Often, patients with vegetation size larger than 20 mm are referred for consideration of open surgical lead extraction and debridement
Mortality rates for infected CIEDs vary in the published literature, with highest rates occuring among patients treated with antibiotics alone (31% to 66%) and as low as 13% to 33% with antibiotics and lead removal
03
34-year-old male
Non-ischemic cardiomyopathy status post implantable cardioverter-defibrillator (ICD) placement 3 months prior to admission
Methicillin-sensitive staphylococcus aureus (MSSA) bacteremia
Vegetations involving his ICD lead and Tricuspid Valve (TV)
Patient History
04
Procedure Notes
Access Sites: AngioVac Cannula and Snare- RIJx2 Re-infusion cannula- LFV Pump Time: 15 minutes Fluoro time: 30 minutes Heparin Total: 20,000 IU ACT: 307 Seconds Preparation Patient was anesthetized, then intubated, and a TEE probe was placed to visualize the TV vegetations. Access was done via a double right internal jugular (RIJ) stick for aspiration, left groin was used for the 20F reinfusion cannula. A 6F sheath was placed in the right gron and at the end of the case was replaced by a dialysis catheter. The left femoral was dilated up to a 18F over a wire, then a 20F percutaneous reinfusion cannula was placed and connected to the circuit via a wet to wet connection and flushed appropriately. RIJ access was serially dilated up to 24F. Heparin was given to achieve an initial ACT of 233. An additional 5000u was provided reaching an ACT of 278. Placement The 26F sheath was then placed over a super stiff wire, into the RIJ with no complications. A 6F sheath was also placed into the RIJ to pass the 35mm goose neck snare through, to help guide the AngioVac as needed. The AngioVac Cannula was attached to the circuit and flushed with normal saline, then placed through the sheath to the superior vena cava (SVC) right atrium (RA) junction, the balloon tip was inflated to 2 atmospheres (ATM), and the centrifugal pump was turned on. Flows were maximized at 2200 revolutions per minute (RPM) = 3.5 liters per minute (LPM). Procedure The AngioVac Cannula was advanced via TEE guidance. The AngioVac Cannula was easily navigated through the RA to debulk the vegetation on the lead and then into the TV while on pump. The vegetations were easily accessed and engaged by the AngioVac Cannula. The physician could feel material coming through the AngioVac Cannula and the vegetations were no longer visible on the TEE. Laser lead extraction was then performed by the throacic surgeons. The AngioVac Cannula was removed and the blood was returned to the patient via gravity feed. The large bore sites were closed via mattress suture. The material was sent to pathology.
05
Results
The following photos are actual procedure results courtesy of Dr. Zlotnick.
†
References
Indication for Use: The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours. Contraindications: The Following contraindications are applicable: • Do not use if the patient has severe arterial or venous vascular disease. • The device is contraindicated in the removal of chronic firmly adherent intravascular material (e.g., atherosclerotic plaque, chronic pulmonary embolism). • The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation. Warnings: • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping. • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred. Failure to inspect could result in injury to patient or user. • Verify that the lumen is patent and that the cannula has not been damaged or kinked prior to use. • Instructions for use and manuals for the AngioVac Cannula and all related accessories and extracorporeal circulatory devices should be read prior to use and devices used as indicated. • Selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians’ sole responsibility. The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique. The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician. • As with all medical devices, this device and ancillary equipment are to be used by trained physicians only. Specifically, this device is to be used only by medical personnel experienced with initiating and monitoring extracorporeal bypass and by physicians trained and experienced using surgical and/or percutaneous (Seldinger) vascular access techniques. • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device. • Do not use in conjunction with a power injector. • Do not alter the AngioVac Cannula in any way. Adverse Events: This device, as do all extracorporeal blood vessel devices, has possible side effects, which include but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques. These may occur if the instructions for use are not followed. Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited t • Air Embolism • Arrhythmias • Blood Loss/Blood Trauma • Death • Damage to Vessel • Device Fracture/Balloon Rupture with Distal Embolization • Distal Embolization of Thrombus • Hematoma • Hemoptysis • Hemorrhage • Local or Systemic Infections • Pleural Effusion • Pulmonary Embolism • Pulmonary Infarction • Vascular Thrombosis • Venous Valve Injury • Ventricular Perforation • Vessel Spasm Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Indication for Use: AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours. Contraindications: Refer to the AngioVac Cannula Directions for Use (DFU) for procedure-specific contraindications. Warnings: • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping. • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred. Failure to inspect could result in injury to patient or user. • Carefully examine the circuit for leaks before and during use. Leakage may result in loss of sterility, blood loss or air embolism. If leakage is observed replace the circuit, the leaking component or tighten the leaking connection. • Instructions for use and manuals for all related extracorporeal circulatory devices should be read prior to use, including but not limited to the AngioVac Cannula, centrifugal pump head, control console and bubble trap. • As with all medical devices, this device is to be used by or under the direction of trained physicians only. • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device. Adverse Events: Possible complications include those normally associated with anticoagulation and extracorporeal circulation. This product, as with all extracorporeal circulatory systems, has possible side effects, which include but are not limited to infections, blood loss/blood trauma, thrombus formation and embolic events. These may occur if the instructions for use are not followed. Refer to AngioVac Cannula DFU for additional listing of potential adverse events. Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
GL/VI/MS/56 Rev 01 1/20
AngioDynamics, the Angiodynamics logo, AngioVac and the AngioVac logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate, or a subsidiary.
1. Harper MW, Uslan DZ, Greenspon AJ, et al. Clinical presentation of CIED infection following initial implant versus reoperation for generator change or lead addition. Open Heart. 2018 March 6;5(1). 2. Issa ZF, Goswami NJ. Simultaneous lead extraction and vacuum-assisted vegetation removal. HeartRhythm Case Rep. 2015 Aug 21;2(1):17-19. 3. Wazni O, Wilkoff BL. Considerations for cardiac device lead extraction. Nat Rev Cardiol. 2016 Apr;13(4):221-9.4 4. Schaerf RHM, Najibi S, Conrad J. Percutaneous Vacuum-Assisted Thrombectomy Device Used for Removal of Large Vegetations on Infected Pacemaker and Defibrillator Leads as an Adjunct to Lead Extraction. J Atr Fibrillation. 2016 Oct 31;9(3):1455.
*Dr. Zlotnick is a paid consultant of AngioDynamics.
Uni-Fuse Overview
Allow for even distribution of lytic agent throughout length of the infusion pattern
Pressure Response Outlets
Supports catheter over bifurcation and is compatible with the self-adjusting occluding wire for pushability and mechanical advantages
Flow-Thru Hub
Allow for easier visualization and placement throughout the vasculature
Radiopaque Markers
Prevents kinking and provides the proper force to activate pressure response outlets
Occluding Ball Wire
Features & Benefits
LEFT POPLITEAL
RIGHT POPLITEAL
RADIAL
Uni-Fuse applications
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INDICATIONS FOR USE: The UNI*FUSE Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature. Contraindications: The UNI*FUSE Infusion System is contraindicated for use in the coronary and cerebral vasculature. The UNI*FUSE Infusion System is not intended for the infusion of blood or blood products. Refer to the product insert of the therapeutic solution for indications, contraindications, side effects, cautions and warnings. Warnings: • Single patient use. Do not re-use or resterilize. • Do not use if package is damaged. • This product should be used only by physicians who have a thorough understanding of angiography and percutaneous interventional procedures. • Do not inject contrast medium with a pressure injector if the occluding ball wire is in place. • Use an introducer sheath if the puncture is through a synthetic graft. • Failure to use an introducer sheath may result in damage to the catheter or occluding ball wire. • Reprocessing may compromise the integrity of the device and/or lead to device failures. • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient. • Complications may occur, if all the air has not been removed from the infusion catheter and displaced with saline prior to insertion into the body. • Never advance the guidewire against resistance; this could cause vessel trauma and/or wire damage. Determine the cause of resistance under fluoroscopy and take any necessary remedial action. Potential Complications: Potential Complications include, but are not limited to Hematoma at the entry site, Vessel perforation, Vasospasm, Hemorrhage, Contrast extravasation, Embolism, Drug reaction, Allergic reaction to contrast media, Neurological deficits including stroke and death, Pain and tenderness, Vessel dissection, Vascular thrombosis, Other - case (or patient) to which the therapeutic solution is inadequate. Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. *AngioDynamics, the AngioDynamics logo, and Uni-Fuse are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. © 2020 AngioDynamics, Inc. GL/VI/TS/461 Rev 01 10/2020
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