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 and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
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.
- The safety and effectiveness of the catheters (including the coated ones) has not been established, or is unknown, in vascular regions other than those specifically indicated.
- Use caution when manipulating, advancing and/or withdrawing the catheter through needles, metal cannulas, stents, or other devices with sharp edges, or through tortuous or calcified blood vessels. Manipulation, advancement, and/or withdrawal past sharp or beveled edges may result in destruction and/or separation of the outer coating, which may lead to clinical adverse events requiring additional intervention, resulting in coating material remaining in the vasculature or device damage.
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, sterile inflammation or granulomas at the access site
- Other AEs: Nerve injury, AV fistula formation, infection, MI, arrhythmia, pulmonary embolism/infarct
