AURYON Instructions for Use June 2022

Instruction For Use

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

Table of contents 1.

Indications for use ... 3

2.

Device Description... 3

3.

Contraindications for Use ... 6

4.

Warnings ... 6

5.

Precautions ... 6

6.

Potential Complications ... 7

7.

How Supplied... 7

8.

Direction for Use... 8

9.

Clinical Data ... 10

10. Limited Warranty ... 15

CAUTION:

FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN WITH APPROPRIATE TRAINING

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Instruction For Use

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

1. Indications for use 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.

2. Device Description The Auryon Atherectomy System includes (A) the Laser System, and (B) the “Auryon” Atherectomy Catheters in a variety of sizes. The Laser System includes in addition to the laser itself, a pump, a sterile aspiration tube, a canister base, a reusable canister, a disposable sterile liner placed within the reusable canister, footswitch pedal, and power cord. For additional information, technical and specific details for the operation of the Laser System itself, please refer to Operator Manual, doc LBL0019. The Laser System has an RFID system for communicating with an RFID tag in each of the disposable catheters. Note: you should not use any other accessories listed above that were not provided by AngioDynamics Inc, its affiliates or subsidiaries (“AngioDynamics”). The Auryon Atherectomy Catheter is a single patient, single use catheter that is made of an array of optic fibers and surrounded and supported by a circumferential blunt blade at its distal tip. The catheter is connected to the Laser System via its connector (on the proximal end) and transmits energy through its active tip (on the distal end) at pre-set controlled level of fluence to the target lesion in the artery. The Auryon catheter is a disposable device, carries an RFID tag and is supplied sterile. All Auryon catheters work over 300cm 0.014” guide wires (GW) that have crossed the target lesion intraluminally. Catheter sizing identification and compatibility to other accessories is printed on its package and described below. Table 1. Auryon catheter models Catheter Tip (outer) Diameter

Cat.#

Reference Vessel Diameter (mm)

GW Compatibility (in.)

Max Tip Diameter (mm/in.)

0.9mm 1.5mm

EXM-4002-0000 EXM-4001-0000

≥1.4 ≥2.25

0.014 0.014

0.97/0.038 1.51/0.059

Max Shaft Diameter (Crossing Profile) (mm/in.) 1.02/0.040 1.56/0.061

Total Working Length (cm)

Minimal Sheath (Fr.)

Inner Lumen for Aspiration

Additional features

150 150

4 5

No No

N/A N/A

Mechanism of action The Auryon Atherectomy System uses laser energy emitted from the tip of the catheter (for partial tissue removal from lesion ("Atherectomy")), in peripheral artery disease (PAD) patients undergoing interventional procedures in the infrainguinal arteries. The Auryon catheter’s blunt blade encircles and supports an array of optical fibers at the tip of the catheter emitting laser energy of 50-60 mJ/mm2 fluence (the Laser System default is 50 mJ/mm2). Once the Auryon catheter is positioned proximally to the target lesion in the artery over a 300cm 0.014” guide wire (GW) that has crossed the lesion in the vessel's lumen, and the Laser System is turned "ON" and is in "ready" mode, short (10-25 ns) ultraviolet 355nm pulses are delivered at 40Hz to the tip of the catheter, in order to photo-ablate fibrous, calcific, thrombotic and atheromatous lesions, in de novo, and restenotic lesions. The laser beam focal point is several dozens of microns ahead of the supporting blunt blade as the device progresses through the locally superficial traumatized lesion.

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Instruction For Use

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

Figure 1: 0.9mm/1.5mm AuryonTM Catheter. Magnified view of the distal end tip shows several rows of fibers.

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Instruction For Use

1. Laser system – The "Laser System" is a console that incorporates the laser head and its optics, a controller, an electrical unit and an "off the shelf" dedicated vacuum pump supplied with the system. In addition, the console is composed of the following components. 2. Key switch – For main system "On" and "Off" control 3. System's aperture (connector housing) 4. Control touch panel – The interface for the laser operator 5. Footswitch pedal – To be pressed and released by the treating physician to activate and deactivate the laser energy 6. EMO (Emergency Machine Off) – A button to be pushed in case of an immediate need to shut off the laser system. 7. LED indicator panel – indicates different levels of laser status: stand by, ready, and active 8. Footswitch pedal cable 9. Reusable Canister (including disposable liner inside). 10. Canister base – to hold the canister for aspiration 11. System's handle 12. Wheels 13. Rear storage compartment to store the footswitch pedal 14. Power cord connector 15. Auryon OTW catheter 16. Power cord

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

Front side of the laser system

Back side of the laser system Note: Not shown is the Sterile Aspiration Tube that will be connected on one side to the catheter handle and the other end to the Disposable Liner's cap (the blue cap shown in item 9 of the image).

Figure 2: Entire system

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*Parts 9 and 10 in this image are not relevant for the 0.9mm/1.5mm catheters

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Instruction For Use

3.

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

Contraindications for Use None.

4.

Warnings Preparation and Operation of the Laser System can be done only by a Laser Operator (technician/nurse/AngioDynamics representative) and the use of the catheter by a physician who were trained by AngioDynamics Inc. representatives for the proper operation of the Laser System, and as outlined within the Operator Manual supplied with each Laser System (See Auryon Atherectomy System Operator Manual, LBL0019) and these Instructions for Use. Any deliberate use of the Auryon Atherectomy System outside its indications for use may result in a severe injury to the patient and will void the manufacturer warranty. Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training. Inspect the Auryon catheter and its package to verify that no damage has occurred as a result of shipping and handling. In the event of damage to the sterile packaging or to the catheter, do not use the catheter, but retain the package with its content and notify an AngioDynamics representative. Use of damaged components may result in system malfunction or patient injury Pay careful attention while using the catheter, avoid excessive force and be on alert for any potential damage. Inadvertent movement of the catheter may result in patient injury. Proximal vessel diameter must be ≥150% of the outer diameter of the Auryon catheter. Always use fluoroscopic surveillance when advancing the Auryon catheter inside the patient vasculature to avoid misplacement, dissection, or perforation. Based on physician discretion, an Embolic Protection Device (EPD) may be used during the procedure. Refer to the selected EPD's instructions for use (IFU) for details on its handling and use. The Laser System is Class 4 laser. Laser safety goggles must be worn by all individuals present in the operating room. If not worn, individuals are subject to permanent damage to the eye by direct exposure or diffuse reflections while the Laser System is in active mode. Make sure to wear the appropriate laser safety goggles as instructed in the Operator Manual. In any case, the Laser System should be active only after the catheter is inside the vascular system and intended to be used at the lesion site. The Laser System has been tested and found to comply with the electromechanical compatibility (EMC) limits for the Medical Device Directive 93/42/EEC (IEC/EN 60601-1-2), for both 110V and 220V electrical net (grid). These limits are designed to provide adequate protection against harmful interference in a typical medical installation. The equipment generates, uses and can radiate, ultraviolet energy and if not used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. Some sources of electromagnetic disturbance, such as, diathermy, lithotripsy, electrocautery, RFID, electromagnetic anti-theft systems, and metal detectors may possibly have interference with the Auryon Atherectomy System. Avoid the above sources from being in the area of the Auryon Atherectomy System when operating.

5.

Precautions Flush the Auryon catheter guide wire (GW) lumen using 5-10cc sterile saline (preferably heparinized) BEFORE introducing the Auryon catheter over the guide wire and insert the GW while continuously hydrating the GW with a soaked sterile pad. • NOTE: Pressurized saline (preferably heparinized) should be continuously fed through the introducer sheath or the guiding catheter that is positioned as close as possible to the Auryon catheter distal tip at a rate of 100ml/min. Saline should be fed during catheter activation. • NOTE: Do not use the Auryon catheter with any other Laser System. • If there is a need to move the bed during the procedure, note not to stretch the catheter's proximal part connected to the Laser System.

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Instruction For Use

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

• NOTE: Vasodilator and anticoagulant therapy (according to the medical facility’s protocol) should be administered to the patient during use of the Auryon Atherectomy System and post procedure as commonly practiced. • After use, dispose of the catheter (and any other disposable components) in accordance with applicable and local instructions relating to hospital waste, and potentially biohazardous materials • Do not attempt to open the Laser System console. The Laser System may be opened/repaired/maintained/fixed only by an AngioDynamics Inc.’s technician (not by the Laser Operator in the site trained by AngioDynamics Inc.). • In case of any technical error or any malfunction, the catheter should not be used. You must use care when handling the Auryon catheter. If you suspect catheter damage, replace this catheter with a new one. Any deliberate misuse by bending, twisting or any other severe physical manipulation may result in injury to the patient and will void the manufacturer warranty.

6. Potential Complications As with the use of similar therapies, the following potential complications may occur with the use of this catheter, accessories, and adjunctive therapies (e.g., balloon, stent, etc.). These complications may include but are not limited to: Procedural Complications: Other Adverse Events Serious Adverse events: • Spasm • Nerve injury • Death • Major dissection • AV fistula formation • Re-intervention • Thrombus • Infection • Acute Limb Ischemia • Distal embolization • Myocardial Infarction • Major amputation • Perforation • Arrhythmia • Bypass surgery In hospital complications: • Hematoma with surgery • Re-occlusion • Stroke • Pseudoaneurysm • Renal failure • Bleeding

7. 7.1

How Supplied Sterilization and sterility period.

The Auryon catheters are single use only. Do not re-sterilize and/or reuse. The Auryon catheters are supplied sterile. Sterility is guaranteed only if the package is unopened undamaged and used before the expiry date. 7.2

Inspection Prior to Use

Before use, visually inspect the sterile package to ensure that seals have not been broken and that the "use by date" has not expired. All equipment to be used for the procedure, including the catheter, should be examined carefully for defects. Examine the Auryon catheter for bends, kinks, or other damage. Do not use if it is damaged or suspected to be damaged.

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Instruction For Use

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

8. Direction for Use NOTE: The atherectomy procedure must be conducted by an AngioDynamics trained physician and an assistant (both must work in sterile conditions). Laser System preparation and operation will be done only by a staff technician trained by AngioDynamics (“Laser Operator”). The Laser Operator will work in non-sterile conditions. 8.1. A recommended matrix for catheter selection per treated lesion's Reference Vessel Diameter (RVD). Table 2. Auryon Atherectomy catheter use matrix. Catheter Tip (outer) Diameter

cat. #

Reference Vessel Diameter (mm) 1

0.9mm

EXM-4002-0000

≥1.4

1.5mm

EXM-4001-0000

≥2.25

1 The RVD should be ≥150% of each catheter diameter tip. It means that a specific size of a catheter should not be inserted to a vessel that has

proximal diameter smaller than indicated.

8.2. Auryon catheter insertion over the guide wire until laser activation: NOTE: For all procedures that involve placing a device into the patient's body, use fluoroscopic guidance. 8.2.1. Once arterial access is achieved, perform baseline angiography to evaluate the PAD and plan on the appropriate catheter size, as well as any accessories that may allow better pushability of the catheter, once inserted. This may include a long sheath and/or guiding catheter (depending on the access approach: retrograde or antegrade). The distal end of the longer sheath/guiding catheter should be placed as close as possible to the lesion, in case of retrograde ("contralateral" or "crossover") approach, tortuous anatomy or highly calcified lesions. Please refer to Table 1 for selecting the minimal sheath size. 8.2.2. Instruct the Laser Operator to prepare the Laser System and instruct the staff on size of the Auryon catheter you wish to operate in this specific procedure. 8.2.3. You may use any other GW to cross the lesion, but the final GW that Auryon catheters will track over should be 300cm 0.014", and preferably stiff GWs. Once this GW is angiographically verified to cross the lesion in the vessel's lumen, it is ready for Auryon catheter insertion over the guide wire. 8.2.4. Open the chosen Auryon catheter as instructed and hand the connector to the Laser Operator for connecting the catheter to the Laser System. Confirm and verify with the Laser Operator that the chosen catheter’s size was identified by the RFID system. Flush the Auryon catheter guide wire's lumen from the handle's luer lock port, using 5-10cc saline (preferably heparinized). The entire guide wire must be soaked with saline before insertion into the GW lumen. The GW is inserted from the distal tip of the catheter toward the handle. The GW lumen is located in the center of the catheter shaft. 8.2.5. Introduce the distal tip of the Auryon catheter over the soaked guide wire, and once in the vessel, under fluoroscopy control, guide the Auryon catheter to the lesion, until the distal tip of the catheter shown on the fluoroscopic monitoring screen is proximal to the lesion. Only at this point of the procedure, instruct the Laser Operator to put the Laser System in Ready mode. Once the Laser Operator has set the Laser System to Ready mode, the Laser System will prepare itself for approximately 15 seconds. During this time, a blue color horizontal LED light on the control touch panel is blinking and at the end of 15 seconds, the blinking ceases and the LED light becomes steady, and this activates the footswitch pedal for use. Once the LED light is steady blue, you may activate the Laser System for "start and stop" by pressing and releasing the footswitch pedal, respectively.

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Instruction For Use

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

8.3. Routine Laser activation and advancement of Auryon catheter through the lesion: 8.3.1. Once the footswitch is pressed and the laser becomes active, begin advancing the Auryon catheter. NOTE: The recommended catheter advancement rate is 1mm/sec. The advancement rate should generally be kept faster than 0.1mm/sec and slower than 3 mm/sec. Avoid higher advancement rates as plaque removal efficiency may be reduced. NOTE: Pressurized saline (preferably heparinized) should be continuously fed through the introducer sheath at a rate of 100ml/min. Saline should be fed during laser activation. NOTE: In case of failure of saline infusion set, stop the laser by releasing the footswitch. After stopping the laser, resume infusion and then activate the laser again. CAUTION: In the unlikely event that the laser does not stop by releasing the footswitch, immediately ask the Laser Operator to power down the entire Laser System by pushing the emergency machine off (EMO) button. Then check for the reason for the footswitch failure and see if can be resolved. If resolvable, ask the Laser Operator to deactivate the EMO and activate the laser again with the footswitch. If not resolvable, remove the catheter from the patient’s body, continue the procedure by other means, and call AngioDynamics’ representative. Do not use the Laser System until the issue is resolved by AngioDynamics’ representative. 8.3.2. Once the desired area is crossed with the Auryon catheter, release the footswitch to stop the laser. At this point, you may choose to repeat lasing at areas of the treated lesion that seemed difficult to cross compared to other areas of the treated lesion. If difficulty to cross was noted, you should retrieve the catheter proximally to the lesion area and advance the catheter to the point(s) where difficulty(ies) was (were) noted and press the footswitch pedal at this(ese) area(s) only. If no difficulty to cross was noted, then one pass is enough, and you can remove the catheter from patient’s the body, and you may or may not visualize the effect at this point. NOTE: If you experience difficulties in retracting the Auryon catheter, do not apply excessive force. The cause of the resistance should be determined under direct fluoroscopic observation before continuing. NOTE: It is expected, especially with chronic total occlusion (CTO) lesions at the cap, that the advancement rate may be slower. In any such case, and in any other occasion that the catheter does not seem to be advancing at a certain point, please follow the instructions below: a) Do not to exceed 10 seconds of continuous lasing at the same location. If you experience any difficulty advancing the Auryon catheter, immediately start a 10-seconds self-count-down. Self-count-down should start the moment you experience non-advancement of the Auryon catheter. When advancement resumes, stop the self-count-down and resume it if additional difficulty advancing the Auryon catheter is experienced. b) If the Auryon catheter cannot be advanced by the 10th second of laser activation, release the footswitch to stop the laser, retract the catheter approximately 3-4 mm, and try to advance again while rotating the catheter shaft approximately 90 degrees to either side, while resuming the 10-second self-count-down . c) If the Auryon catheter still cannot be advanced with the above-mentioned rotation manipulation for the additional 10-seconds, immediately stop the laser activity by releasing the footswitch . d) Ask the Laser Operator to raise the fluence to the 60mJ/mm2. e) Activate the laser and try again to advance the Auryon catheter through the lesion. f) If the Auryon catheter cannot be advanced, resume the 10-second self-count-down. g) If the Auryon catheter cannot be advanced in this attempt, stop the laser activity, withdraw the Auryon catheter and use a new catheter. When done, release the footswitch to stop the laser, and then retrieve the catheter out of the body. 8.3.3. Perform adjunctive therapy such as balloon angioplasty or stenting, if deemed necessary, and conclude the procedure per common practice.

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Instruction For Use

9.

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

Clinical Data

EX-PAD-01 The EX-PAD-01 clinical study was a prospective, single-arm, multi-center, international, open-label, non-randomized clinical study to assess safety, performance and efficacy of the Auryon Atherectomy Catheter in subjects with Peripheral Artery Disease (PAD) in lower extremity arteries. Fifty (50) subjects were enrolled from October 2015 until July 2017 in two European investigational sites. The primary safety endpoints were perioperative (until discharge) freedom from clinically significant device related adverse events requiring intervention (perforation, dissection, distal embolization or pseudo-aneurysm) and freedom from Major Adverse Events (MAE) at 30 days, defined as target lesion revascularization, unplanned target limb amputation above the ankle, and cardiovascular deaths. The primary efficacy endpoint was technical success, defined as the ability of the Auryon catheter to cross the target lesion stenosis over the guide wire (in true lumen) while the Minimal Lumen Diameter (MLD) is smaller than the Auryon catheter diameter. The perioperative freedom from clinically significant device related adverse events was 100%. Freedom from MAE at 30-days was 100% (50/50), freedom from MAE at 6 months was 100.0% (50/50), and freedom from MAE at 12 months in 46 subjects that completed the follow up was 95.6% (44/46). Technical success was achieved in 100.0% (49/49) of the treated lesions. Table 3 below summarizes the safety and effecacy data resulting from the EX-PAD-01 study.

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Instruction For Use

Table 3: Summary of safety and efficacy results in EX-PAD-01 study Parameter

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

Results (n=50 subjects, 53 lesions)

Demographics Male

76% (38/50)

Age (years)

64.0 ± 8.5

Diabetes Mellitus

18% (9/50)

Target Lesion characteristics Superficial Femoral Artery (SFA)

85.0% (45/53)

Popliteal

7.6% (4/53)

Femoro-Popliteal

3.8% (2/53)

Tibial-Peroneal Trunk

3.8% (2/53)

Moderate-Severe Calcification

60.8% (31/51)

Average Lesion length (cm)

7.4 ± 5.5

% residual stenosis Pre-Auryon

95.3 ± 10.3

% residual stenosis Post-Auryon

61.3 ± 25.5

Final Diameter stenosis (%)

14.0 ± 14.0

Procedural Settings Number of catheters used [SD]

1.2 ± 0.5

Technical success

100% (52/52)

Safety results 30 days Major Adverse events2 and perioperative until discharge clinically significant device related adverse events requiring intervention

0.0% (0/50)3,4

1

6 months Major Adverse events

0.0% (0/50)5

12 months Major Adverse events

4.3% (2/46)6

Efficacy results Baseline ABI

0.57 ± 0.1

30 days ABI

0.94 ± 0.1

6 months ABI

0.84 ± 0.2

12 months ABI

0.77 ± 0.2

Baseline Rutherford

2.82 ± 0.52

30 days Rutherford

0.66 ± 0.76

6 months Rutherford

0.90 ± 1.03

12 months Rutherford

1.21 ± 1.0

1

Defined as the ability of the Auryon catheter to cross the target lesion stenosis over the guide wire while the stenotic flow diameter is smaller than the Auryon catheter diameter 2 Major Adverse Events were defined as cardiovascular death, TLR, unplanned amputation above the ankle or emergent surgical revascularization of the target limb 3 There were 2 post procedure access site hematoma unrelated to the device, which required limited local surgical treatment that led to prolongation of hospitalization (non-device related SAE), and were resolved by discharge. 4 No dissections/perforations revealed after catheter pass. In 3 cases, as expected, dissections were noted only post balloon inflation, and which were treated with stent or did not require treatment, and all 3 cases were considered unrelated to the Auryon System. 5 Two subjects did not come to their follow up at 6 months clinic visit yet confirmed freedom from MAE by phone. 6 Four subjects were lost to follow up at 12 months visit, resulting in 46 subjects who confirmed freedom from MAE.

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Instruction For Use

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

EX-PAD-03 The EX-PAD-03 clinical study was a pivotal, prospective, single-arm, multi-center, international, open-label clinical study to assess safety and efficacy of the Auryon Atherectomy catheter in subjects with infra-inguinal Peripheral Artery Disease (PAD). Ninety-seven (97) subjects were enrolled from September 2017 until March 2018 in eight (8) US investigational sites and three (3) European investigational sites. The primary safety endpoint was freedom from Major Adverse Events (MAE) through a 30-day follow-up period, as adjudicated by the Clinical Event Committee (CEC), defined as clinically driven target lesion revascularization (CDTLR), unplanned target limb amputation above the ankle, and cardiovascular deaths. This endpoint is considered to be met if the rate is greater than 85%. The primary efficacy endpoint was acute technical success, defined as reduction from baseline in residual diameter stenosis (measured in percent), prior to any adjunctive therapy, achieved by the Auryon Atherectomy catheter, as assessed quantitatively by the core laboratory based upon the procedure angiograms. This endpoint is considered to be met if the mean reduction in residual diameter stenosis is greater than 20%, prior to any adjunctive therapy. Freedom from MAE at 30-days was 98.9% (92/93). The reduction from baseline in residual diameter stenosis (measured in percent), achieved by the Auryon Atherectomy catheter, as assessed quantitatively by the core laboratory based upon the procedure angiograms was 33.6% (± 14.2%). Table 4 below summarizes the safety and efficacy data resulting from the EX-PAD-03 study.

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Instruction For Use

Table 4: Summary of safety and efficacy results in EX-PAD-03 study Parameter

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

Results (n=97 subjects, 107 lesions)

Demographics Male

52.5% (51/97)

Age (years)

70.5 ± 9.9

Diabetes Mellitus

42.3% (41/97)

Target Lesion characteristics Iliac-SFA

0.9% (1/107)

CFA-SFA

5.6% (6/107)

SFA

61.7% (66/107)

SFA-Popliteal

6.5% (7/107)

Popliteal

7.5% (8/107)

Popliteal-TPT

2.8% (3/107)

Popliteal-AT

1.9% (2/107)

Popliteal-Peroneal

2.8% (3/107)

TPT

0.9% (1/107)

TPT-Peroneal

0.9% (1/107)

TPT-PT

0.9% (1/107)

AT

5.6% (6/107)

Peroneal

0.9% (1/107)

PT

0.9% (1/107)

Chronic Total Occlusion or sub-occlusions (stenosis > 95%)

32.7% (32/107)

Moderate Calcification

12.1% (13/107)

Severe Calcification

26.2% (28/107)

RVD – proximal (mm)

4.5 ±1.1

Lesion length (cm)

5.4 ± 4.3

% residual stenosis Pre-Auryon

85.7 ± 12.2

% residual stenosis Post-Auryon

52.1 ± 14.9

% reduction of residual stenosis post Auryon

33.6 ± 14.2

Final Diameter stenosis (%)

17.7 ± 11.0

Procedural Settings Number of catheters used [SD]

1.2 ± 0.5

Primary efficacy endpoint

33.6% ± 14.2

Primary safety endpoint Freedom from Major Adverse Events (MAE)7 through a 30-day followup period, as adjudicated by the Clinical Event Committee (CEC)

98.9% (92/93)

Secondary Efficacy results

7

Major adverse events were defined as: Unplanned target limb amputation above the ankle, Clinically Driven Target Lesion Revascularization (CDTLR), Cardiovascular related deaths IFU0110-01, Jun 2022

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Instruction For Use

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

Baseline ABI

0.71±0.19 (N=88)

30 days ABI

0.95 ± 0.14 (N=88)

Baseline Rutherford

2.77±0.6 (N=97)

30 days Rutherford

0.98 ± 1.01 (N=94)

Baseline WIQ questionnaire

0.23 ± 0.22 (N=93)

30 days WIQ questionnaire

0.50 ± 0.32 (N=84)

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Instruction For Use

10.

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

Limited Warranty

Warranty Summary • The Auryon Atherectomy System and Auryon Atherectomy Catheters (“Products”) are warranted free from defects in material or workmanship for 1 year from the date of delivery to the purchaser. • Warranty repairs can be obtained by calling AngioDynamics’ customer service department at +1 800-772-6446. • All returned products must be prepaid and have a return materials authorization (RMA) number. • Certain hardware and software updates or upgrades may be provided at no charge during the Warranty Period when Products are returned to AngioDynamics. • Unauthorized repairs, misuse, or abuse of the Products will void the warranty. AngioDynamics warrants to the initial purchaser that the Products will be free from defects in material or workmanship, under normal, proper, and intended usage, for a period of one (1) year from the date of initial shipment to purchaser (“Warranty Period”). Excluded from this warranty are expendable components and supply items such as, but not limited to, power cords, footswitches, and cables. AngioDynamics’ obligations under this warranty are to repair or replace any Products (or part thereof) that AngioDynamics reasonably determines to be covered by this warranty and to be defective in workmanship or materials, provided that the purchaser has given notice of such warranty claim within the Warranty Period and the Product is returned to AngioDynamics with freight prepaid. Repair or replacement of Products under this warranty does not extend the Warranty Period. To request repair or replacement under this warranty, purchaser should contact AngioDynamics directly (see contact information on the back cover of this manual). AngioDynamics will authorize purchaser to return the Product (or part thereof) to AngioDynamics. AngioDynamics shall determine whether to repair or replace Products and parts covered by this warranty and all Products or parts replaced shall become AngioDynamics’ property. In the course of warranty service, AngioDynamics may, but shall not be required to, make engineering improvements to the Product or part thereof. If AngioDynamics reasonably determines that a repair or replacement is covered by the warranty, AngioDynamics shall bear the costs of shipping the repaired or replacement Product to purchaser. All other shipping costs shall be paid by purchaser. Risk of loss or damage during shipments under this warranty shall be borne by the party shipping the Product. Products shipped by purchaser under this warranty shall be packaged in the original shipping container or equivalent packaging to protect the Product. If purchaser ships a Product to AngioDynamics in unsuitable packaging, any physical damage present in the Product on receipt by AngioDynamics (and not previously reported) will be presumed to have occurred in transit and will be the responsibility of purchaser. This warranty does not extend to any Products or part thereof: that have been subject to misuse, neglect, or accident; that have been damaged by causes external to the Product, including but not limited to failure of or faulty electrical power; that have been used in violation of AngioDynamics’ instructions; that have been affixed to any nonstandard accessory attachment; on which the serial number has been removed or made illegible; that have been modified by anyone other than AngioDynamics; or that have been disassembled, serviced, or reassembled by anyone other than AngioDynamics, unless authorized by AngioDynamics. AngioDynamics shall have no obligation to make repairs, replacements, or corrections which result, in whole or in part, from normal wear and tear. AngioDynamics makes no warranty (a) with respect to any products that are not Products; (b) with respect to any products purchased from a person other than AngioDynamics or an AngioDynamics-authorized distributor; or (c) with respect to any product sold under a brand name other than AngioDynamics. THIS WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY FOR ANGIODYNAMICS’ PRODUCTS, EXTENDS ONLY TO THE PURCHASER, AND IS EXPRESSLY IN LIEU OF ANY OTHER EXPRESS OR IMPLIED WARRANTIES INCLUDING WITHOUT LIMITATION ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. ANGIODYNAMICS’ MAXIMUM LIABILITY ARISING OUT OF THE SALE OF THE PRODUCTS OR THEIR USE, WHETHER BASED ON WARRANTY, CONTRACT, TORT, OR IFU0110-01, Jun 2022

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Instruction For Use

0.9mm/1.5mm Auryon Atherectomy catheter OTW For Infra-Inguinal Atherectomy

OTHERWISE, SHALL NOT EXCEED THE ACTUAL PAYMENTS RECEIVED BY ANGIODYNAMICS IN CONNECTION THEREWITH. ANGIODYNAMICS SHALL NOT BE LIABLE FOR ANY INCIDENTAL, SPECIAL, OR CONSEQUENTIAL LOSS, DAMAGE OR EXPENSE (INCLUDING WITHOUT LIMITATION LOST PROFITS) DIRECTLY OR INDIRECTLY ARISING FROM THE SALE, INABILITY TO SELL, USE OR LOSS OF USE OF ANY PRODUCT. EXCEPT AS SET FORTH HEREIN, ALL PRODUCTS ARE SUPPLIED “AS IS” WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED. THESE TERMS MAY NOT BE ALTERED, AMENDED, REPLACED, SUBSTITUTED, OR RESCINDED BY ANY EMPLOYEE, AGENT, INDEPENDENT CONTRACTOR, OR CONSULTANT OF ANGIODYNAMICS. ANY SUCH ALTERATION, AMENDMENT, REPLACEMENT, SUBSTITUTION, OR RESCISSION SHALL NOT BE BINDING UPON ANGIODYNAMICS, ITS AFFILIATES, OR SUBSIDIARIES. Performing unauthorized service or repairs not described in these instructions for use or a Product manual will void the Product’s warranty. Products marked as “single-use” are for single use only. Purchaser shall not reuse, reprocess, or reserialize single-use Products. Reuse, reprocessing, or reserialization may compromise the structural integrity of the Product and/or lead to Product failure, which may result in patient injury, illness, or death. Reuse, reprocessing, or reserialization may also create a risk of contamination of the Product 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 Product may lead to injury, illness, or death of the patient. AngioDynamics assumes no liability with respect to single-use Products reused, reprocessed, or reserialized and makes no warranties, express or implied, including, without limitation, any implied warranties of merchantability or fitness for a particular purpose, with respect to any such Product. For additional product information or to report any technical issue with the products, please contact: [email protected]

Eximo Medical Ltd. 3 Pekeris, Einstein building, Tamar Park, Rehovot,7670203, Israel Phone: +972 (8) 6307630 Fax: +972 (8) 6307631

Distributed in the US by: AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 USA USA Customer Service 800-772-6446

*AngioDynamics, Auryon, the Auryon logo, are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. IFU0110-01, Jun 2022

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