13. CLEANING ........................................................................................................................................22

14. PRODUCT HANDLING .....................................................................................................................22

15. TROUBLESHOOTING ......................................................................................................................23

16. PRODUCT DISPOSAL .....................................................................................................................23

17. SYMBOLS AND NOMENCLATURE DESCRIPTION .......................................................................24

18. ORDERING INFORMATION ............................................................................................................25

19. PRODUCT ORDERS AND RETURNS .............................................................................................25

ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS ........................................................26

20. PRODUCT DESCRIPTION ...............................................................................................................27

21. WARNINGS AND PRECAUTIONS ...................................................................................................28

22. CLINICAL STUDIES .........................................................................................................................31

23. ELECTRICAL CLASSIFICATION .....................................................................................................53

24. ELECTROMAGNETIC COMPATIBILITY GUIDANCE ......................................................................53

25. CONTACT INFORMATION ..............................................................................................................57

Caution: Heathcare provider authorisation required.

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Summary of Contents for ElectroCore gammaCore Sapphire

Page 1: Table Of Contents
(non-invasive vagus nerve stimulator) INTENDED USE AND PRODUCT DESCRIPTION ................2 WHAT SHOULD I EXPECT? ......................3 COMMON SIDE EFFECTS ASSOCIATED WITH gammaCore Sapphire ..........5 WILL I STILL NEED TO TAKE MEDICATIONS? ................5 WARNINGS AND PRECAUTIONS .....................5 POTENTIAL RISKS AND COMPLICATIONS ASSOCIATED WITH VAGUS NERVE STIMULATION ..8 DISPLAY SYMBOLS ..........................9...
Page 2: Intended Use And Product Description
1. INTENDED USE AND PRODUCT DESCRIPTION gammaCore Sapphire (non- invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for the treatment and/ or prevention of primary headache (migraine, cluster headache, and hemicrania continua) and medication overuse headache in adults.
Page 3: What Should I Expect
2. WHAT SHOULD I EXPECT? People respond differently to nVNS. Preventive Treatment of Cluster Headache For the preventive treatment of cluster headache, and unless otherwise directed by your HCP, two self-administered treatments consisting of three consecutive 2-minute stimulations should be applied daily.
Page 4 Acute Treatment of Migraine For the acute treatment of migraine, and unless otherwise directed by your HCP, each self- administered treatment should consist of two 2-minute stimulations applied at the onset of pain or symptoms. Stimulations may be applied to either side ofthe neck. If the pain has not decreased 20 minutes after the start of your first treatment, you may administer an additional treatment consisting of two 2-minute stimulations.
Page 5: Common Side Effects Associated With Gammacore Sapphire
3. COMMON SIDE EFFECTS ASSOCIATED WITH gammaCore The most common side effects (reported in more than 1% of patients who participated in gammaCore studies) include: • Application site discomfort • Application site irritation/redness • Local pain, face/head/neck area (including toothache) •...
Page 6 (eg, mobile phone) • Contact your HCP if your symptoms continue or worsen. • Treatment is intended to be given (administered) as directed by an HCP. Your HCP or electroCore Customer Service must train you in the proper use of gammaCore.
Page 7 • Exposure to extreme hot or cold temperatures outside the range of 0°C to 38°C (32°F to 100°F) may cause the device to not work properly. Keep gammaCore away from things like fireplaces and heaters. • Do not attempt to replace the device battery. If the device is not working, contact electroCore Customer Service. 64000-00126 Rev 2...
Page 8: Potential Risks And Complications Associated With Vagus Nerve Stimulation
• Do not open or take apart the case or attempt to repair or modify the device. There are no user- servicable parts. If the device is not working, contact electroCore Customer Service. • Do not intentionally damage, burn, or puncture the device.
Page 9: Display Symbols
7. DISPLAY SYMBOLS Icon Description Icon Example Display Description 6 treatments remaining Treatments Remaining within a 24- hour period Intensity level Intensity Level is at 23 30 days remaining until Days Remaining device will not deliver stimulations Intensity Level Last delivered intensity at Last Use level was 23 Battery...
Page 10: Device Status Indicators
Device turns off Complete automatically 3. Last Intensity Level Used Device turns off automatically after Repeated long 10 seconds Error beeps Restart device (Turn off and on again)* *If error is not resolved, contact electroCore Customer Service. 64000-00126 Rev 2...
Page 11 Station Remove device from charging station and place back in* Charging Repeated long Unplug charging base Error beeps power adapter from the outlet and plug in again* *If error is not resolved, contact electroCore Customer Service. 64000-00126 Rev 2...
Page 12 Customer Service* Wait 24 hours and Card Error None restart device (turn off and on again)* *If error is not resolved, contact electroCore Customer Service. Note: The remainder of this page was intentionally left blank. 64000-00126 Rev 2...
Page 13: Reloading Instructions
Turn device off and try again. NOTE: If 5 consecutive reload errors occur, “Ec” will be displayed. Wait 24 hours and retry, or contact electroCore Customer Service. Note: The remainder of this page was intentionally left blank.
Page 14: Charging Instructions
6. If “Er” is displayed on the device, unplug the power cord from the outlet and plug in again. If “Er” remains on the device’s display, please contact electroCore Customer Service. NOTE: Charge your device before first use. Allow 6 to 7 hours for a full charge.
Page 15: Functions
11. FUNCTIONS Power Button Increase Intensity Decrease Intensity Press the power button to turn device ON Press the upper area of Press the lower area of the control button the control button Hold the power button to turn the device OFF 64000-00126 Rev 2...
Page 16: How To Use Gammacore Sapphire
12. HOW TO USE gammaCore Sapphire Set Up 1. Remove any jewelry that may touch the treatment location. 2. Find a comfortable sitting position. (A place where you can see your neck in a mirror would be helpful.) 3. Locate the treatment location by finding the pulse on the side of the neck.
Page 17 CAUTION: Only use an electroCore- approved gel with gammaCore. Please contact electroCore Customer Service for an electroCore- approved gel that works with the device (refer to Section 25). 64000-00126 Rev 2...
Page 18 Delivering Treatment a. Removing gammaCore from the neck b. Lowering the intensity level by pressing the bottom area of the control button c. Repositioning gammaCore on the neck over the pulse and slowly increasing the intensity level again by pressing the top area of the control button If the stimulation is still intolerable, turn the device off by pressing and holding the power button and...
Page 19 If you are not pain free 2 hours after the start of the first treatment, you may administer a third treatment consisting of two consecutive 2-minute stimulations. Please see Figure 4 at the end of this section for an example of the acute treatment of one migraine.
Page 20 Figure 1. Preventive Treatment of Cluster Headache* *The first treatment consists of three consecutive 2-minute stimulations applied to either side of the neck within 1 hour of waking. A second treatment of three consecutive 2-minute stimulations should be applied at least 7-10 hours after the first daily treatment. Figure 2.
Page 21 Figure 3. Preventive Treatment of Migraine* *The first treatment consists of two consecutive 2-minute stimulations applied to either side of the neck within 1 hour of waking. A second treatment of three consecutive 2-minute stimulations should be applied mid-day. A third treatment of three consecutive 2-minute stimulations should be applied in the evening.
Page 22: Cleaning
• Do not submerge the device in water; it is not water resistant. • Do not use soap, hand sanitizer, detergents, or other cleansers when cleaning the device. 14. PRODUCT HANDLING Operating Conditions – gammaCore Sapphire • Range: 0°C to 38°C (32°F to 100°F) • Humidity: 10% to 90% •...
Page 23: Troubleshooting
• Ensure the charging cord is plugged into a live power outlet. • Ensure charging cord is plugged into the charging case. gammaCore has no stimulations left/days left • Reload gammaCore with a gammaCore Refill Card. If necessary, contact electroCore Customer Service to order a refill card. 16. PRODUCT DISPOSAL Regulations require that disposal of electrical and electronic equipment, including used and unused medical devices, is handled in a controlled manner.
Page 24: Symbols And Nomenclature Description
17. SYMBOLS AND NOMENCLATURE DESCRIPTION Expiration date Follow operating instructions Lot number Manufacturer Protection from solid foreign objects IP22 Catalog number / Reference number ≥12.5 mm and ingress of water at 15° Electric shock hazard Type BF applied part Serial number Storage temperature Date of manufacture on package label, xxyyGzzzz...
Page 25: Ordering Information
19. PRODUCT ORDERS AND RETURNS To learn more about ordering gammaCore, call electroCore Customer Service. Requests to return a device, including a non- working device, should be made to electroCore Customer Service. Refer to Section 25 for electroCore Customer Service Contact Information.
Page 26: Additional Information For Healthcare Providers
ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS 64000-00126 Rev 2 64000-00126 Rev 2...
Page 27: Product Description
The patient applies electroCore-approved gel to the stimulation surfaces to maintain an uninterrupted conductive path from the stimulation surfaces to the skin on the neck. Tubes of electroCore-approved gel are provided with each gammaCore starter kit and refill kit for this purpose. The stimulation surfaces are capped when not in use.
Page 28: Warnings And Precautions
21. WARNINGS AND PRECAUTIONS Warnings indicate instructions, which, if not followed, may result in serious injury or death to the device user or to the patient. Precautions indicate instructions, which, if not followed, may result in damage to the equipment or degradation in the quality of treatment.
Page 29 • The HCP should train patients in the proper use of gammaCore, inform them of all potential risks and complications of treatment, and provide accompanying device labeling. • Only use an electroCore- approved gel with gammaCore. Please contact electroCore Customer Service for an electroCore- approved gel that works with the device.
Page 30 If the battery becomes depleted, place in the charging station to recharge. o To contact electroCore Customer Service if the device is not working. They should not attempt to open the case, replace the battery, or disassemble, repair or modify the device.
Page 31: Clinical Studies
22. CLINICAL STUDIES Clinical data demonstrating the safety and effectiveness of gammaCore for the acute treatment of episodic cluster headache is presented from two prospective, double- blind, sham- controlled, randomized clinical trials (ACT1 and ACT2). Summary In both studies, gammaCore did not provide a significant improvement over a sham (placebo) device in the total patient population, which included patients with episodic cluster headache (eCH) and chronic cluster headache (cCH).
Page 32 Demographics ACT1 enrolled a total of 150 patients with cluster headache. Overall, 101 of the patients had eCH and 49 had cCH. General demographics are provided in Table 1. Table 1. ACT1 Demographics By Treatment Group By Cohort (N=150) (N=150) nVNS Sham eCH Cohort...
Page 33 Efficacy Primary End Point The primary efficacy end point in the ACT1 Study was the percentage of patients who reported mild or no pain 15 minutes after treatment initiation with gammaCore for the first treated CH attack in the study; rescue medication use within 60 minutes was considered a treatment failure. The results for the primary end point in the total population were 26.7% in the nVNS group and 15.1% in the sham group, which was not significant (P=0.1).
Page 34 Table 2. ACT1 Key End Points (mITT Population Unless Otherwise Indicated) All Subjects eCH Cohort cCH Cohort nVNS Sham nVNS Sham nVNS Sham End Point (n=60) (n=73) (n=38) (n=47) (n=22) (n=26) Primary end point (all subjects) 26.7 15.1 34.2 10.6 13.6 23.1 Response rate (%)
Page 35 Safety gammaCore was found to be safe and well tolerated in this study. The majority of the adverse events were mild and transient and occurred during the time of active treatment. None of the serious adverse events were considered device related. Please see Table 3 for complete details. Table 3.
Page 36 Study 2: gammaCore for the Acute Treatment of Chronic and Episodic Cluster Headache: The ACT2 Study In ACT2, subjects were instructed to treat their cluster headache attack at the onset of pain with three 2-minute stimulations (Figure 6). If pain was still present at 9 minutes, the subjects had the option of treating with an additional three 2-minute stimulations.
Page 37 Demographics ACT2 enrolled a total of 102 patients with cluster headache. General demographics are provided in Table 4. Table 4. ACT2 Demographic and Baseline Characteristics (Safety Population) By Treatment Group By Cohort (N=102) (N=102) nVNS Sham eCH Cohort cCH Cohort Characteristic (n=50) (n=52)
Page 38 Efficacy The primary end point in the ACT2 Study was the percentage of total attacks that were pain-free 15 minutes after the initiation of treatment with the device with no use of rescue medication through the treatment period (30 minutes). The results for the primary end point in the total population were 13.5% in the nVNS group and 11.5% in the sham group and were not statistically significant (P=0.71).
Page 39 Table 5. ACT2 Key End Points (mITT Population Unless Otherwise Indicated) All Subjects eCH Cohort cCH Cohort nVNS Sham nVNS Sham nVNS Sham End Point (n=48) (n=44) (n=14) (n=13) (n=34) (n=31) Primary end point (all subjects) Attacks that were pain free 13.5 11.5 47.5...
Page 40 Safety gammaCore was found to be safe and well tolerated in this study. The majority of the adverse events were mild and transient and occurred during the time of active treatment. None of the serious adverse events were considered device related. Please see Table 6 for complete details. Table 6.
Page 41 Summary Analysis of ACT1 and ACT2 Studies To further define the therapeutic benefit of gammaCore for the treatment of cluster headache, the results of both studies were examined to assess the overall response to each study’s primary end point. Please see Table 7 for complete details. Table 7.
Page 42 Table 8. ACT2 Primary End Point: Number (%) of All Attacks in Randomized Period Pain Free at 15 Minutes, No Rescue Medication P-value nVNS Sham GEE Model GEE Model Adjusted % Adjusted % (95% CI) (95% CI) Model ACT1 Population Total 28/259 (10.8) 11.5 (7.0, 18.4)
Page 43 Acute Migraine Headache Clinical Study Clinical data demonstrating the safety and effectiveness of gammaCore for the acute treatment of migraine headache is presented from one prospective, double-blind, sham-controlled, randomized clinical trial (The PRESTO Study). Summary This randomized, sham-controlled trial demonstrated the safety and efficacy of gammaCore for the acute treatment of episodic migraine with or without aura.
Page 44 Demographics PRESTO enrolled a total of 243 patients with migraine. General demographics are provided in Table 9. Table 9. PRESTO Demographics and Subject/Attack Characteristics (ITT Population) By Treatment Group (N=243) nVNS Sham Characteristic (n=120) (n=123) At Baseline Age (y), mean±SD 38.8 ±...
Page 45 Efficacy Primary End Point The proportion of participants who became pain-free for the first treated migraine attack approached but did not reach statistical significance at 120 minutes (nVNS, 30.4%; sham, 19.7%; P = 0.067; primary end point; logistic regression analysis); however, a consistent trend was observed, with significance achieved at both 30 minutes (nVNS, 12.7%;...
Page 46 Table 10. PRESTO Key Efficacy End Points (Double-blind Period; ITT Population; N = 243) 30 Min 60 Min 120 Min gammaCore Sham gammaCore Sham gammaCore Sham Primary endpoint (pain-free) – logistic regression 12.7 21.0 10.0 30.4 19.7 95% CI 7.2, 21.6 1.7, 9.6 14.1, 30.1 5.6, 17.4...
Page 47 Safety gammaCore was found to be safe and well tolerated in the PRESTO study. The majority of the adverse events were mild and transient and occurred during the time of active treatment. None of the serious adverse events were considered device related. Please see Table 11 for complete details. Table 11.
Page 48 Preventive Treatment of Cluster Headache 76 Clinical Study Clinical data demonstrating the safety and effectiveness of gammaCore for the preventive treatment of cluster headache are presented from one prospective, open-label, controlled, randomized clinical trial (The PREVA Study). Summary This randomized, controlled trial demonstrated the safety and efficacy of gammaCore for the preventive treatment of cluster headache.
Page 49 Demographics PREVA enrolled a total of 114 patients with cluster headache. General demographics are provided in Table 12. Table 12. Demographic and Baseline Characteristics (ITT Population) gammaCore + SoC Alone Characteristic SoC (n=48) (n=49) Age, y, mean (SD) 45.4 (11.0) 42.3 (11.0) Sex, n (%) Male...
Page 50 Efficacy Primary End Point In the ITT population (Standard of Care (SoC) plus nVNS, n=45; control, n=48), subjects receiving SoC plus nVNS during the randomized phase had a greater reduction from baseline ( 5.9; SE, 1.2) in the number of CH attacks per week than those receiving control ( 2.1; SE, 1.2), for a mean therapeutic gain of 3.9 fewer CH attacks per week (95% CI: 0.5, 7.2; P=0.02). In the site-adjusted model, the mean therapeutic gain was 4.2 fewer headache attacks per week (95% CI: 0.8, 7.5;...
Page 51 Table 13. PREVA Key Efficacy End Points (Double-blind Period; 139 ITT Population; N = 93) gammaCore + SoC SoC Alone (n=45) (n=48) Primary endpoint (ITT population Change in number of CH attacks per week 5.9 ± 1.2 2.1 ± 1.2 (mean ± SE) Mean therapeutic gain (fewer CH attacks per week) Unadjusted 95% CI 0.5, 7.2...
Page 52 Safety gammaCore was found to be safe and well tolerated in the PREVA study. The majority of the adverse events were mild and transient and occurred during the time of active treatment. None of the serious adverse events were considered device related. Please see Table 14 for complete details. Table 14.
Page 53: Electrical Classification
23. ELECTRICAL CLASSIFICATION ❖ Electrical Classification (gammaCore) • UL 60601-1 Class III; EN 60601-1 Internally Powered Equipment • Type BF Applied part • IP22 Protected against ingress of solid foreign objects ≥ 12.5 mm diameter and protected against vertically falling water drops when enclosure tilted up to 15° •...
Page 54 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and gammaCore The customer or the user of gammaCore can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and gammaCore, as recommended below, according to the maximum output power of the communications equipment.
Page 55 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity gammaCore is intended for use in the electromagnetic environment specified below. The customer or the user of gammaCore should assure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic Test Test Level Level...
Page 56 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity gammaCore is intended for use in the electromagnetic environment specified below. The customer or the user of gammaCore should ensure that it is used in such an environment. Electromagnetic IEC 60601 Compliance Immunity Test Environment - Test Level Level...
Page 57: Contact Information
Any attempt to access, copy, remove, modify, reprogram, de- compile, or otherwise use any software licensed hereunder in any manner inconsistent with this license grant shall entitle electroCore to terminate the license.
Page 58 Inc. 150 Allen Road, Suite 201 Basking Ridge, NJ 07920 United States 1 (888) 903-CORE (2673) www.electrocore.com...

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