ElectroCore gammaCore-S Instruction Manual

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Instructions for Use for gammaCore

INTENDED USE & PRODUCT DESCRIPTION .......................................................... 2

WHAT SHOULD I EXPECT? ....................................................................................... 2

WILL I STILL NEED TO TAKE MEDICATIONS? ......................................................... 3

WARNINGS AND PRECAUTIONS .............................................................................. 3

POTENTIAL RISKS AND COMPLICATIONS .............................................................. 6

DISPLAY SYMBOLS ................................................................................................... 7

TROUBLESHOOTING/DEVICE STATUS INDICATORS............................................. 8

BUTTON FUNCTIONS ...............................................................................................11

HOW TO USE gammaCore ....................................................................................... 12

10.

CLEANING ................................................................................................................ 17

11.

PRODUCT HANDLING ............................................................................................. 17

12.

PRODUCT DISPOSAL .............................................................................................. 17

13.

SYMBOLS AND NOMENCLATURE DESCRIPTION ................................................ 18

14.

ORDERING INFORMATION ..................................................................................... 19

15.

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

ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS .................................... 20

16.

PRODUCT DESCRIPTION ....................................................................................... 21

17.

WARNINGS AND PRECAUTIONS ............................................................................ 22

18.

POTENTIAL ADVERSE REACTIONS ....................................................................... 25

19.

CLINICAL STUDIES .................................................................................................. 26

20.

CONTACT INFORMATION ........................................................................................ 47

Caution: Rx Only. US Federal Law restricts this device to sale by or on the

order of a licensed healthcare provider.

-S

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Summary of Contents for ElectroCore gammaCore-S

Page 1: Table Of Contents
Instructions for Use for gammaCore ® INTENDED USE & PRODUCT DESCRIPTION ............2 WHAT SHOULD I EXPECT? ..................2 WILL I STILL NEED TO TAKE MEDICATIONS? ............3 WARNINGS AND PRECAUTIONS ................3 POTENTIAL RISKS AND COMPLICATIONS .............. 6 DISPLAY SYMBOLS ....................7 TROUBLESHOOTING/DEVICE STATUS INDICATORS..........
Page 2: Intended Use & Product Description
1. INTENDED USE AND PRODUCT DESCRIPTION gammaCore-S (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 acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.
Page 3: Will I Still Need To Take Medications
You may administer gammaCore for up to 4 attacks (or 8 separate treatments) per day (for a total of 24 stimulations per day). The length of each stimulation (120 seconds) provides a sufficient amount of time for correct positioning of gammaCore and for setting the appropriate stimulation strength. For episodic cluster headache: One treatment is defined as three consecutive 2-minute stimulations lasting 120 seconds (2 minutes).
Page 4 Warnings • The safety and effectiveness of gammaCore (nVNS) have not been established in the acute treatment of chronic cluster headache. • This device has not been shown to be effective for the prophylactic treatment of migraine headache, chronic cluster headache, or episodic cluster headache. •...
Page 5 • Contact your HCP if your symptoms continue or worsen. • Treatment is intended to be given (administered) by a clinician in a healthcare facility or as directed by an HCP. Your HCP or electroCore Customer Service must train you in the proper use of gammaCore.
Page 6: Potential Risks And Complications
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. • Do not open or take apart the case, or attempt to repair or modify the device. There are no user serviceable parts.
Page 7: Display Symbols
6. DISPLAY SYMBOLS Icon Icon Description Example Display Display Description Stimulations Remaining 9 stimulations remaining Stimulation intensity at 20, Stimulation Intensity V symbol indicates a signal at stimulation surfaces 15 days remaining until Days Remaining device expires and will not deliver stimulations Stimulation Last stimulation intensity...
Page 8: Troubleshooting/Device Status Indicators
7. TROUBLESHOOTING / DEVICE STATUS INDICATORS gammaCore has a visual indicator (light and display) and an auditory signal (beep) to indicate device status. Status Light Display Sound User Action 1. Number of Days Remaining Green Light On Follow Start Up / Ready 1 short beep after “How to Use”...
Page 9 Status Light Display Sound User Action 1. Number of Days Remaining None 2. Number of Stimulations Remaining NONE: Stimulation Device turns off 2 short beeps Complete automatically 3. Last Stimulation Intensity Flashing Green Light Device turns off automatically after 10 seconds Repeated long Error beeps...
Page 10 None Dead Battery None None Replace device* * Contact electroCore Customer Service if error is not cleared or to order a new device. Note: The remainder of this page was intentionally left blank. 64000-00120 Rev 3...
Page 11: Button Functions
8. BUTTON FUNCTIONS (+) and (-) Buttons pressed (+) Button (-) Button at the same time Turns device ON; Increases Decreases stimulation Turns device OFF stimulation intensity intensity Note: The remainder of this page was intentionally left blank. 64000-00120 Rev 3...
Page 12: How To Use Gammacore
9. HOW TO USE gammaCore Set Up Remove any jewelry that may touch the treatment location. Find a comfortable sitting position. (A place where you can see your neck in a mirror would be helpful). Locate the treatment location by finding the pulse on the side of the neck.
Page 13 Not applying the gel as described may cause the stimulation to be uncomfortable or less effective. 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 22).
Page 14 Delivering Treatment c. Repositioning gammaCore on the neck over the pulse and slowly increasing the stimula- tion intensity again by pressing the (+) button. If the stimulation is still intolerable, turn the device off by pressing the (+) and (-) buttons at the same time and discontinue the stimulation.
Page 15 10. After each stimulation, remove the device and turn it off by pressing the (+) and (-) buttons at the same time or wait for the device to automatically turn off. After completing the stimulation, the device will display the number of stimulations and days remaining and the last stimulation intensity before automatically turning off.
Page 16 Figure 1. Treating an episodic cluster headache* *One treatment consists of three consecutive 2-minute stimulations at the onset of pain; if pain is still present 3 minutes after the first treatment, a second treatment of three consecutive 2-minute stimulations may be applied. You may treat up to 4 attacks per day; however, do not exceed 24 stimulations per day.
Page 17: Cleaning
Contact electroCore Customer Service if you have questions about the appropriate disposal of this device.
Page 18: Symbols And Nomenclature Description
13. SYMBOLS AND NOMENCLATURE DESCRIPTION Expiration date Follow operating instructions Lot number Manufacturer Protection from solid foreign objects IP22 Catalogue 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 19: Ordering Information
40000-00103 Conductive Gel 15. PRODUCT ORDERS AND RETURNS Returns of a non-working device should be reported to electroCore customer service. For Contact Information, refer to Section 22. Note: The remainder of this page was intentionally left blank. 64000-00120 Rev 3...
Page 20: Additional Information For Healthcare Providers
ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS 64000-00120 Rev 3 64000-00120 Rev 3...
Page 21: Product Description
The stimulation surfaces are capped when not in use.
Page 22: Warnings And Precautions
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 23 • 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 24 Not to use the device after its expiration date. The expiration date is indicated on the device packaging. 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 25: Potential Adverse Reactions
18. POTENTIAL ADVERSE REACTIONS Potential risks associated with non-invasive vagus nerve stimulation that may be mild to moderate: o Transient laryngeal irritation, dysphagia, dyspnea, cough, hoarseness or change in voice tone o Muscle twitching, discomfort, or pain during stimulation o Dysgeusia due to treatment The above should resolve after treatment is complete.
Page 26: Clinical Studies
19. CLINICAL STUDIES Acute cluster headache 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 (The ACT1 and ACT2 Studies). 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...
Page 27 Demographics The ACT1 study enrolled a total of 150 patients with cluster headache. 101 of the patients had eCH and 49 had cCH. General demographics are provided in the following table: Table 1. ACT1 Demographics By Treatment Group By Cohort (N=150) (N=150) nVNS...
Page 28 Efficacy Primary End Point The primary efficacy end point for 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 29 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 30 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 31 Study 2: gammaCore for the acute treatment of chronic and episodic cluster headache: The ACT2 Study In the ACT2 study, subjects were instructed to treat their cluster headache attack at the onset of pain with three 2-minute stimulations (Figure 4). If pain was still present at nine minutes the subjects had the option of treating with an additional three 2-minute stimulations.
Page 32 Demographics The ACT2 study enrolled a total of 102 patients with cluster headache. General demographics are provided in the following table: 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)
Page 33 Efficacy The primary outcome for effectiveness defined 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 significant (P=0.713).
Page 34 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 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 6 for complete details. Table 6.
Page 36 Summary Analysis of ACT1 and ACT2 Studies To further define the therapeutic benefit of gammaCore for the acute treatment of pain associated with episodic cluster headache, the results of both studies were examined to assess the overall response to each study’s primary end point. Table 7.
Page 37 Table 8. ACT2 Primary End Point: Number (%) of All Attacks in Randomized Period Pain Free at 15 Minutes, No Rescue Medication nVNS Sham P value GEE Model GEE Mode Adjusted % Adjusted % (95% CI) (95% CI) model ACT1 Population Total 28/259 (10.8) 11.5 (7.0,18.4)
Page 38 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 39 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 ± 11.0 39.6 ± 11.8 Age (y), mean±SD 38.8 ± 11.0 39.6 ± 11.8 Age of migraine onset (y), mean±SD 29.4 ±...
Page 40 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 signifi- cance achieved at both 30 minutes (nVNS, 12.7%;...
Page 41 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 regession 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 42 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 11 for complete details. Table 11.
Page 43: Contact Information
(b) repairs or modifications performed other than by electroCore or an electroCore authorized repair facility; (c) use of the device in any manner other than for which it is intended; or (d) any special, indirect and/or consequential damages of any kind and however caused arising from the sale or use of the product.
Page 44 LLC 150 Allen Road, Suite 201 Basking Ridge, New Jersey 07920 United States +1 (888) 903 2673 www.electrocore.com...

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