S4 Peripheral IVL Catheter Instructions for Use Rev B June 2018

Devices Required But Not Supplied By Shockwave Medical, Inc. • • •

5F introducer sheath 0.014” (0.36mm) Guide Wire (300cm Length) 5”x96” (13x244 cm) minimum Sterile Sleeve

Shockwave S4 Peripheral IVL Catheter Balloon Compliance Chart Pressure ATM – kPA 4 – 405 5 – 507 6 – 608 7 – 709 8 – 811 9 – 912 10 – 1013

2.5 x 40mm Ø (mm)* 2.42 2.44 2.45 2.47 2.50 2.52 2.54

3.0 x 40mm Ø (mm)* 2.93 2.96 3.00 3.03 3.06 3.09 3.11

3.5 x 40mm Ø (mm)* 3.38 3.41 3.45 3.50 3.54 3.57 3.60

4.0 x 40mm Ø (mm)* 3.87 3.91 3.96 4.01 4.05 4.09 4.12

Note: 4 ATM is lithotripsy treatment balloon pressure, 6 ATM is nominal balloon pressure and post-treatment angioplasty pressure and 10 ATM is RBP (Rated Burst Pressure) of the balloon.

Shockwave S4 Peripheral IVL System Sequence Chart The following Shockwave S4 Peripheral IVL System pulsing sequence must be followed during treatment. Do not utilize a pulsing sequence other than those outlined in the IVL System Sequence Chart below. Insertion of any size IVL Catheter will automatically program the IVL Generator with the following treatment sequence: Treatment Frequency Maximum Number of Continuous Pulses (1 cycle) Minimum Pause Time Maximum Total Pulses Per Catheter

1 Pulse per Second 20 Pulses 10 Seconds 160 (8 Cycles)

In the event the user attempts to deliver more than the maximum number of continuous pulses allowed, the IVL Generator is designed to stop automatically. To resume pulsing, wait at least the minimum pause time before resuming therapy. The therapy button must be released and pressed again to resume therapy. For more information, refer to the IVL Generator and Connector Cable Operator’s Manual. The IVL Catheter will deliver a maximum of 160 pulses or 8 cycles noted above. If this count is reached, the catheter shall not be used any further. If further therapy is needed, discard this catheter and obtain a new one. Caution: Do not exceed 160 pulses in the same treatment segment. Contraindications for Use The IVL System is contraindicated for the following: 1. 2. 3.

Unable to pass 0.014” guidewire across the lesion. This device is not intended for treatment of in-stent restenosis. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.

Warnings 1. 2. 3. 4. 5. 6.

This device is intended for single (one) time use only. DO NOT re-sterilize and/or reuse. Do not use a device past the expiration date on the label. Use of expired product may result in patient injury. Always insert the IVL Connector Cable into a sterile sleeve prior to use. Use only an appropriately sized balloon for the vessel to be treated. Inflate the balloon according to the balloon compliance chart. Balloon pressure should not exceed the rated burst pressure (RBP). Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding. 7. Use the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. Do not attempt to override the lifetime pulse limits per device as defined in the IVL System Sequence Chart. 8. This device should only be used by physicians who are familiar with interventional vascular procedures. 9. Physicians must read and understand these instructions prior to use of the device. 10. Do not use excessive force/torque when using this device as this could result in damage to the device components and patient injury. 11. Inspect all product components and packaging prior to use. Do not use the device if it or the packaging has been damaged or if sterility has been compromised. Damaged product could result in patient injury. 12. For preparation, operation, warnings and precautions, and maintenance of the IVL Generator and its accessories refer to the IVL Generator and Connector Cable Operator’s Manual.

Precautions 1. 2. 3. 4. 5. 6.

Perform all device manipulations under adequate fluoroscopic guidance. Use only the recommended balloon inflation medium. Appropriate anticoagulant therapy should be administered by the physician. Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology. Care should be taken not to kink the catheter. If kinking occurs, remove device and prepare a new device. If an inability to inflate or maintain pressure occurs, remove the catheter and use a new device.

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7. 8.

If the catheter appears not to deliver lithotripsy pulsatile mechanical energy, remove and replace it with another catheter. Precaution should be taken when handling device after exposure to patient e.g. contact with blood. Used product is considered biohazardous material and should be disposed of properly as per hospital protocol.

Adverse Effects Possible adverse effects are consistent with standard angioplasty and include: • • • • • • • • • • • • • • • • • • • • • • • •

Access site pain Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy Arterial dissection Arterial perforation or rupture Arterial spasm Arteriovenous fistula Bleeding complications Death Emboli (air, tissue, thrombus or atherosclerotic emboli) Emergency or non-emergency arterial bypass surgery Entry site complications Fracture of the guide wire or any component of the device that may or may not lead to device embolism, serious injury or surgical intervention Hematoma at the vascular access site(s) Hemorrhage Hypertension/Hypotension Infection/sepsis Ischemia Placement of a stent Pseudoaneurysm Renal failure Restenosis of the treated segment Shock/pulmonary edema Total occlusion of the peripheral artery Vascular complications which may require surgical repair (conversion to open surgery)

Risks identified as unique to the device and its use: • • •

Allergic/immunologic reaction to the catheter material(s) or coating Device malfunction or failure Excess heat at target site due to malfunction of IVL Generator

Summary of Clinical Studies To evaluate the safety and performance of the IVL System, Shockwave Medical, Inc. conducted a two-phased, non-randomized, multi-center study for the treatment of peripheral stenotic lesions (PAD I and PAD II, combined referred to as the DISRUPT PAD Program). Patients with peripheral arterial disease of Rutherford Category 2, 3, and 4 who were candidates for percutaneous therapy and met the study criteria were enrolled and treated. Thirtyfour (34) investigators participated at seven (7) sites in Austria, New Zealand, and Germany. A total of 95 subjects were enrolled. This clinical study summary presents outcomes from all 95 subjects at 30 days and at 6 months. A total of 95 subjects were enrolled in the study. Baseline characteristics were consistent with a complex, calcified patient population. Calcium burden was significant with severe calcification involving both sides of the arterial wall observed by the Core Lab in 54.7% of the subjects, and an average length of calcium of 93.4 mm. Ninety-four (94) of the 95 subjects received treatment with the IVL System. The procedures were completed with a low use of adjunctive therapies including pre and post-dilatation balloons and embolic protection filters, along with a low use of stents in this difficult to treat population. The study met its primary safety endpoint. The lower bound of the 95% confidence interval for freedom from Major Adverse Events (MAE) at 30 days of 97.0% was above the performance goal of 91.3%. The freedom from MAE at 30 days was 100%. The study also met its primary effectiveness endpoint. The lower bound of the 95% confidence interval for procedural success of 97.0% was above the performance goal of 89.3%. Procedural success was defined as <50% with or without adjunctive therapy was 100%. The secondary safety endpoint, freedom from MAE at 6 months, continued to be favorable as shown in the table below. Freedom from MAE at 6 months was 96.8%. There were no cardiovascular deaths, target limb major amputations, perforations, symptomatic thrombus or distal embolization events.

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Freedom from Major Adverse Events at 6 Months N=95 30 days n=941

6 months n=932

Major adverse events (MAE)

0 (0.0%)

3 (3.2%)

Death (cardiovascular)

0 (0.0%)

0 (0.0%)

TLR

0 (0.0%)

3 (3.2%)

Unplanned target limb amputation (above the ankle)

0 (0.0%)

0 (0.0%)

Freedom from Major adverse events (MAE)

94 (100%)

90 (96.8%)

Exact Binomial one-sided lower 95% CI[1]

97%

92%

Death (cardiovascular)

94 (100%)

93 (100%)

TLR

94 (100%)

90 (96.8%)

Unplanned target limb amputation (above the ankle)

94 (100%)

93 (100%)

1 One subject withdrew consent and was not available for analysis 2 Two subjects withdrew consent and were not available for analysis

Secondary effectiveness endpoints were also favorable. Procedural success defined as <50% without adjunctive therapy was achieved in 91.6% of subjects. In addition, procedural success defined as ≤30% with or without adjunctive therapy was achieved in 89.5%. Target lesion patency assessed by duplex ultrasound at 30 days and 6 months was 100% and 76.7% respectively as shown in the table below. Freedom from target lesion revascularizations (TLR) at 6 months was 96.8% for a true rate of 3.2%. Patency at 6 Months N=95 Patency Target lesion patency at 30 days

91/911 (100%)

Exact Binomial Two-sided 95% CI[1]

96%, 100%

Target lesion patency at 6 months

69/902 (76.7%)

Exact Binomial Two-sided 95% CI[1]

67%, 85%

Freedom from TLR at 6 months

90/933 (96.8%)

Exact Binomial Two-sided 95% CI[1]

91%, 99%

1

Two subjects withdrew consent and data for an additional 2 subjects was not available at 30 days 2 Two subjects withdrew consent and data for an additional 3 subjects was not available at 6 months 3 Two subjects withdrew consent and data was not available for analysis

Functional outcomes including change in ankle-brachial index (ABI), Rutherford Category and walking impairment showed a sustained and statistically significant improvement from baseline and data available at 30 days and 6 months. In conclusion, the DISRUPT PAD program met the study success criteria. The IVL System demonstrated compelling safety with minimal vessel injury, and minimal use of stenting. Acute effectiveness results showed high procedural success and a large acute gain in vessel diameter post procedure. Patency, TLR and functional outcomes were durable through 6 months in available patients. These results demonstrate the safety and performance of the IVL System for the treatment of subjects with calcified, stenotic lesions.

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Procedural Steps Caution: Refer to the IVL Generator and Connector Cable Operator’s Manual for preparation, operation, warnings and precautions, and maintenance of the IVL Generator and IVL Connector Cable. Preparation 1. 2. 3. 4. 5.

Prepare the insertion site using standard sterile technique. Achieve vascular access and place an introducer sheath. Select a balloon catheter size that is 1.1:1 based on balloon compliance chart (above) and reference vessel diameter. Remove the IVL Catheter from the package. Prepare the balloon using standard technique. Fill a 20cc syringe with 5cc of 50/50 saline/contrast medium. Attach syringe to inflation port on catheter hub. Pull vacuum at least 3 times, releasing vacuum to allow the fluid to replace the air in the catheter. 6. Fill indeflator device with 10cc of 50/50 saline/contrast medium. Disconnect syringe and connect indeflator to inflation port of catheter hub ensuring no air is introduced to the system. 7. Flush the guidewire port with saline. 8. Remove the protection sheath from the catheter. 9. Wet the balloon and distal shaft with sterile saline in order to activate the hydrophilic coating. 10. Insert the IVL Connector Cable into a sterile sleeve or probe cover. 11. Remove the cap from the proximal end and attach the IVL Catheter’s connector (see Fig 1) to the IVL Connector Cable. 12. Attach the other side of same IVL Connector Cable to the IVL Generator.

Caution: Do not press the therapy button unless the balloon is filled with 50% saline/ 50% contrast medium because this may damage the balloon. Delivering the IVL Catheter to the Treatment Site 1. 2. 3.

Advance the 0.014” guidewire across the treatment site. Load the IVL Catheter over the exchange length (300cm) 0.014” guidewire and through the sheath and advance balloon to the treatment site. Position the balloon at the treatment site using the marker bands to aid in positioning.

Treating the Site with Lithotripsy 1. 2. 3. 4. 5. 6. 7. 8.

Once the IVL Catheter is in place, record position using fluoroscopy. If position is incorrect, adjust the IVL balloon to the correct position. Inflate IVL balloon to 4.0 atm. Deliver IVL System treatment sequence per the IVL System Sequence Chart. Inflate balloon per balloon compliance chart (above) and record lesion response on fluoroscopy. Following lithotripsy treatment, deflate balloon and wait 30 seconds to re-establish blood flow. Repeat steps 3, 4, 5, 6 to complete a single treatment with 40 pulses. Additional treatments can be performed if deemed necessary. If multiple inflations are required due to a lesion length greater than the IVL balloon length, the recommended balloon overlap is at least 1 cm to prevent geographic miss. Caution: Care must be taken not to exceed 160 pulses in the same segment. 9. Perform a completion arteriogram to assess post intervention result. 10. Deflate the device and confirm that the balloon is fully deflated prior to removing the IVL Catheter. 11. Remove the IVL Catheter. If there is difficulty in removing the device through the hemostatic valve due to the lubricity, gently grasp the catheter with sterile gauze. 12. Inspect all components to ensure that the catheter is intact. If a device malfunction occurs or any defects are noted on the inspection, flush the guide wire lumen and clean the outer surface of the catheter with saline, store the catheter in a sealed plastic bag, and contact Shockwave Medical, Inc. for further instructions.

Caution: IVL Catheter once pulled out of the body should not be reinserted for additional inflation or lithotripsy treatments. Balloon can be damaged in the process.

Patient Information Physicians should instruct patients to seek medical attention immediately for signs and symptoms of decreased peripheral blood flow. There are no known limitations to normal daily activities. Patients should be instructed to comply with the medical regimen as prescribed by their physician. Return of Devices If any portion of the Shockwave Medical IVL System fails prior to or during a procedure, discontinue use and contact local representative and/or email [email protected]. Patents: www.shockwavemedical.com/patents Shockwave Medical, Inc. 48501 Warm Springs Blvd., Suite 108 Fremont, CA 94539, USA www.shockwavemedical.com

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Symbol

Definition Do not re-use

Use by date

Sterilized using irradiation

Caution

Manufacturer

Do not use if package is damaged

Keep dry Authorized Representative in the European Community Keep away from heat

Batch code Catalogue number

Do not resterilize

Non-pyrogenic

Consult instructions for use

Contains 1 unit (Contents: 1)

Recommended Guidewire

Recommended Introducer Sheath

Balloon Diameter Balloon Working Length Catheter Working Length (Usable Length, UL) Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. Conformité Européene

PAT

Patents. Refer to www.shockwavemedical.com/patents

IVL

Intravascular Lithotripsy

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PN 61773 Rev. B