Click below for the science behind Auryon
Click below to see Auryon in action
Targeted biological reactions
Addresses risk of perforation 3x higher affinity to lesion tissue vs blood vessel endothelium Vaporizes lesions without thermal ablation
Click below to learn about the the Auryon system
Risk Information & Trademarks
RISK INFORMATION Caution: Federal (USA) law restricts the use of the system by or on the order of a physician. 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. INDICATIONS FOR USE The AURYON™ Atherectomy System is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR). Contraindications The use of AURYON™ Atherectomy System is contraindicated where patients are contraindicated for intravascular intervention for PAD. Warnings The AURYON™ Atherectomy System is a Class IIb medical device which contains a Class IV laser that produces an invisible beam of high-energy ultraviolet radiation. Improper use of the AURYON™ Atherectomy System could result in serious personal injury. Observe all safety precautions for use of Class IV laser equipment. The AURYON™ Atherectomy System contains high voltages which are potentially lethal. To avoid electrical shock, do not open the AURYON™ Atherectomy System cover. Internal maintenance of the system must be performed only by personnel from AngioDynamics. Ensure the system is connected to the proper voltage. The voltage rating is marked on the back panel of the laser controller. Operating the system at the incorrect voltage may result in damage to the system units. The system is not intended to be used during a defibrillation event. Skin exposure to laser radiation should be avoided. Possible explosion hazard if the laser is used in the presence of flammable anesthetics or other solutions and gases. The laser beam may ignite solvents of adhesives and flammable solutions. Allow flammable materials to evaporate before the laser is used. Only catheters approved by AngioDynamics are allowed to be used in the AURYON™ Atherectomy System. AngioDynamics supplies sterile fiber optic catheters. Sterility is guaranteed only if the package is unopened, undamaged and before the expiry date. Pay attention when handling the AURYON™ OTW catheter to ensure that the fibers at the distal and proximal ends are not damaged. When moving the AURYON™ Atherectomy System be careful to avoid crashing or sudden impacts. Before moving the system, release the wheels from locking, disconnect the footswitch pedal cable from its connector in the laser system and place the footswitch pedal in the rear storage compartment. After the system is positioned for use, lock the wheels, take out the footswitch pedal from the rear storage compartment, connect the footswitch pedal cable to the laser system and place the footswitch pedal on the floor. Adverse Events As with the use of similar therapies, the following potential complications may occur with the use of this catheter, accessories and adjunctive therapies (Balloon/stent). These complications may include but are not limited to: Serious Adverse events: Death, re-intervention, ALI, major amputation, bypass surgery, hematoma with surgery, stroke Procedural Complications: Spasm, major dissection, thrombus, distal embolization, perforation In hospital complications: Re-occlusion, pseudoaneurysm, renal failure, bleeding Other AEs: Nerve injury, AV fistula formation, infection, MI, arrhythmia
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2
Longer wavelength (355 nm) Shorter pulse (10-25 ns)
Clinically proven to handle moderate to severe calcium Optimal for treating all types of lesions
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Solid State Delivery
Reliable and stable Quiet, no toxic gases, no calibration burden on staff, minimal warm-up Portable, with a small footprint and uses standard 110-volt power outlet
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References
REFERENCES - Science 1. Herzog A, Bogdan S, Glikson M, Ishaaya AA, Love C. Selective tissue ablation using laser radiation at 355 nm in lead extraction by a hybrid catheter; a preliminary report. Lasers Surg Med. 2016;48(3):281-287. 2. Auryon. Instructions for use. AngioDynamics; 2020. 3. Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644. 4. Polanyi TG. Physics of surgery with lasers. Clin Chest Med. 1985;6(2):179-202. 5. Akkus NI, Abdulbaki A, Jimenez E, Tandon N. Atherectomy devices: technology update. Med Devices (Auckl). 2015;8:1-10. 6. Rawlins J, Din JN, Talwar S, O’Kane P. Coronary intervention with the Excimer laser: review of the technology and outcome data. Interv Cardiol. 2016;11(1):27-32. 7. Jacques SL. Role of tissue optics and pulse duration on tissue effects during high-power laser irradiation. Appl Opt. 1993;32(13):2447-2454. 8. Beek JF, van der Meulen FW, Gijsbers GHM, Welch AJ, Hogervorst W, van Gemert MJC. Laser physics and laser-tissue interaction. Laser Surg Child. 1998;10-49. 9. Herzog A, Steinberg I, Gaisenberg E, Nomberg R, Ishaaya AA. A route to laser angioplasty in the presence of fluoroscopy contrast media, using a nanosecond-pulsed 355-nm laser. IEEE J Sel Top Quantum Electron. 2016;22(3):342-347. 10. Taylor RS, Higginson LAJ, Leopold KE. Dependence of the XeCl laser cut rate of plaque on the degree of calcification, laser fluence, and optical pulse duration. Lasers Surg Med. 1990;10(5):414-419. 11. Photonics Media. Shorter pulse widths improve micromachining. https://www.photonics.com/Articles/Shorter_Pulse_Widths_Improve_Micromachining/a54123. Published June 2013. Accessed March 20, 2020. REFERENCES: - Features 1. Rundback J, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Novel laser-based catheter for peripheral atherectomy: 6 -month results from the Eximo Medical B-LaserTM IDE study. Catheter Cardiovasc Interv. 2019;1-8. 2. Shammas NW, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Acute and 30-day safety and effectiveness evaluation of Eximo Medical’s B-LaserTM, a novel atherectomy device, in subjects affected with infrainguinal peripheral arterial disease: Results of the EX-PAD-03 trial. Cardiovas Revasc Med. 2020;21(1):86-92. 3. Auryon. Instructions for use. AngioDynamics; 2020. 4. Herzog A, Bogdan S, Glikson M, Ishaaya AA, Love C. Selective tissue ablation using laser radiation at 355 nm in lead extraction by a hybrid catheter; a preliminary report. Lasers Surg Med. 2016;48(3):281-287. 5. Herzog A, Steinberg I, Gaisenberg E, Nomberg R, Ishaaya AA. A route to laser angioplasty in the presence of fluoroscopy contrast media, using a nanosecond-pulse 355-nm laser. IEEE J Sel Top Quantum Electron. 2016;22(3):342-347. 6. Kuczmik W, Kruszyna L, Stanisic MG, Dzieciuchowicz L, Ziaja K, Zelawski W, et al. Laser atherectomy using the novel B-LaserTM catheter, for the treatment of femoropopliteal lesions: twelve-month results from the EX-PAD-01 study. Not yet published. 7. Cross FW, Bowker TJ. The physical properties of tissue ablation with Excimer lasers. Med Instrum. 1987;21(4):226-230. 8. Vogel A , Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644.
Click above to go to the Auryon website
The Auryon ATherectomy System
Read Case Study
Say good-bye to complicated
Debulking power and discerning precision
All catheters work over a standard 0.014-inch guide wire.
Purpose-built catheters are designed to treat both above and below the knee, including the ankle.
Treat any infrainguinal artery
The next generation of peripheral atherectomy technology
Popliteal + superficial femoral artery
Reference vessel diameter: ≥3.6 mm Built-in aspiration capability Off-centering mechanism Cleared for ISR
Femoropopliteal + tibioperoneal trunk
Reference vessel diameter: ≥3.0 mm Built-in aspiration capability Cleared for ISR
Tibial + femoropopliteal
1.5-mm catheter Below the knee Reference vessel diameter: ≥2.25 mm
Below the ankle + tibials
0.9-mm catheter Below the knee/ankle Reference vessel diameter: ≥1.4 mm
1,3
Treat calcification with the Auryon system
Clinically proven performance in a broad range of disease severity
97
symptomatic (Rutherford 2-4) patients with peripheral artery disease (PAD)
lesions
107
A multinational pivotal trial* involved
both office-based labs and hospitals
1,2
90
70
60
50
Key 6-month safety results- 107 lesions
PATIENT AND LESION CHARACTERISTICS
42%
22%
21%
86%
77%
diabetic
occluded
restenotic
stenotic
had calcification 38% had moderate to severe calcium
femoral, 8% popliteal, and 18% tibial
74%
KEY 6-MONTH CLINICAL EFFICACY RESULTS
reduction in stenosis prior to any adjunctive therapy regardless of calcification level, lesion type, lesion length, or catheter used 20% stenosis after percutaneous transluminal angioplasty (PTA)
31% 38%
of lesions had clinically driven target lesion revascularizations (CD-TLRs) 0 were in-stent restenosis (ISR)
3%
93%
of patients showed improvement in Rutherford 2-point average improvement
TO
Studied in a real-world patient population
Consistency despite calcification
Improvements in stenosis and patency were consistent across all levels of calcification and types of lesions
Comparable reduction in stenosis regardless of calcification level
*Study design : EX-PAD-03 (clinicaltrials.gov identifier: NCT03157531) was a pivotal study under investigational device exemption from the FDA. EX-PAD-03 was a prospective, single-arm, international, multicenter, open-label clinical study that assessed the safety and efficacy of the Auryon system in subjects with symptomatic (Rutherford 2-4) infrainguinal PAD at 8 US and 3 EU sites. †Segments analyzed by Core Lab and included calcification level: none, mild, moderate, severe; lesion type: general, ISR, chronic total occlusion (CTO), severe calcification; lesion length: 0-50 mm, 51-100 mm, 101-150 mm, 151-250 mm; catheter: 0.9+1.5 mm, 2.0 mm, 2.35 mm.
Baseline
Post Auryon
The Auryon system is the next generation of peripheral atherectomy technology.
The science behind the Auryon system
Click the home icon to return to the booth
Risk Information
ANGM 1206 US Rev. 01 10/19 AngioDynamics and the AngioDynamics logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate, or a subsidiary. Indications for Use: The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for treatment of incompetent (i.e. refluxing) perforator veins (IPVs). Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment. Extremely tortuous vein segments may require treatment by alternative techniques (phlebectomy, sclerotherapy). 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. Treatent of a vein located close to the skin surface may result in a skin burn. Paresthesia may occur from thermal damage to adjacent sensory nerves. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for any person present in the operating room. Prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending. Do not coil the fiber tighter than a radius of 60 mm. The positions of the Site Marks on the EVLT fiber have been matched to the introducer sheath provided in the VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit. Alternative sheaths must not be substituted. Do not tighten the compression clamp on sheath until fiber is in position. Laser protective eye wear must be worn by everyone in the treatment room including the patient. Adverse Events: Potential complications include, but are not limited to the following: DEHP Exposure, Deep Venous Thrombus, Hematoma, Hemorrhage, Infection, Necrosis, Neovascularization, Non-Target Irradiation, Paresthesia, Phlebitis, Pulmonary Embolism, Skin Burns and Pain, Infection, Skin Pigmentation Alteration, Thrombophlebitis, Thrombosis, and Vessel Perforation. 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.
*The SeCure study data was presented and discussed at the ACP meeting (6-8 November, Nashville, TN); VEITH symposium (13–17 November, New York, USA) and the IVC meeting (2-4 April, Miami, FL)
1. Gohel, M., Heatley, F., Liu, X., Bradbury, A., Bulbulia, R., Cullum, N., Epstein, D., Nyamekye, I., Poskitt, K., Renton, S., Warwick, J. and Davies, A. (2018). A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. New England Journal of Medicine, 378(22), pp.2105-2114.1. 2. Barwell J, Davies C, Deacon J. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): Randomized controlled trial. ACC Current Journal Review. 2004;13(8):23-24. doi:10.1016/j.accreview.2004.07.117.
The wave makes the difference
Wavelength (nm) The distance between 2 successive waves determines absorption rate and penetration depth5
Longer wavelengths are absorbed at a shallower depth, resulting in vessel wall preservation and nonreaction to contrast media5,9 Ability to simultaneously ablate and observe fluoroscopy image.9
Lower photon energy is high enough to ablate lesions but low enough to preserve the vessel wall3 Addresses the risk of perforations.1
Shorter pulse width allows for the delivery of greater power to ablate calcified lesions7,11 Plasma formation allows for vaporization of calcium without thermal ablation.3
The efficiency and efficacy of the ablation process are affected by both the target tissue’s composition and structure and the energy delivered.4
Auryon is designed to deliver an optimized wavelength, pulse width, and amplitude to remove calcified lesions while preserving vessel wall endothelium.1-3
The science behind Auryon
Say good-bye to tough.
Precision
Power
3x higher affinity for lesion tissue vs vessel endothelium, giving you the ability to ablate the lesion while preserving vessel endothelium1 Nonreactive to contrast media, allowing you to simultaneously debulk lesions and monitor fluoroscopy images9
The precision of 355-nm wavelength
10- to 25-ns pulse width with 40-Hz amplitude allows for high power output, resulting in calcium debulking2 Plasma formation results in vaporization of tissue without thermal ablation3
Power to debulk any type of lesion (from thrombotic to severely calcified)
Each type of tissue interacts differently with a given wavelength To initiate a photochemical effect, the photon energy of the beam must be higher than the dissociation energy of the target molecular bond Longer wavelengths are absorbed at shallower depths than shorter wavelengths, resulting in lower photon energies
Why does it matter?
Why wavelength matters
Photon Energy
Auryon produces a photon energy of 3.5 eV, which is low enough to be nonreactive to vessel endothelium, but high enough to vaporize calcium
9
Pulse Width
The Auryon system has a pulse width of 10 to 25 ns
355 nm
3.5 eV
< 25 ns
Pulse width (ns) The duration of each pulse determines level of diffusion6,7
Amplitude (mJ/mm2) The height of the wave determines power6,8
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.
2020, AngioDynamics, Inc.
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.
AngioDynamics, the AngioDynamics logo, AngioVac and the AngioVac logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate, or a subsidiary.
