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44 

 
 

The following table identifies all 62 nonserious AEs that were study-related. 

Table 23.  Summary of study-related, nonserious AEs (following activation) 

Event Description 

Number of 

Events 

Number of 

Subjects 

Percent of Subjects 

(n/N) 

Charger stopped working 

1 

1 

1.00% (1/100)

a

 

Device pocket heating while 
charging 

1 

1 

1.00% (1/100)

a

 

Diminished or loss of stimulation* 

9 

7

†

 

7.00% (7/100)

a

 

Diminished or loss of symptom 
relief* 

23 

14

†

 

14.00% (14/100)

a

 

Increased pain 

1 

1 

1.00% (1/100)

a

 

Infection 

2 

2 

2.00% (2/100)

a

 

Local skin erosion 

1 

1 

1.00% (1/100)

a

 

Persistent pain and/or numbness 

6 

6 

6.00% (6/100)

a

 

Postoperative low back pain 

1 

1 

1.00% (1/100)

a

 

Seroma at the implant site 

1 

1 

1.00% (1/100)

a

 

Stimulation in wrong place** 

6 

4

†

 

4.00% (4/100)

a

 

Unpleasant sensations** 

7 

6

†

 

6.00% (6/100)

a

 

Weakness 

3 

3 

3.00% (3/100)

d

 

Total

 

62

 

31

‡

 

31.00% (31/100)

 

* Undesirable changes in stimulation 
** Unintended effects of stimulation 

†

 Some subjects experienced more than one event. 

‡

 The total number of subjects who experienced at least one event listed from the previous rows 

a

 Subjects at risk out of subjects who had the implanted system activated 

 

Summary of Contents for Proclaim 3660

Page 1: ...Proclaim Implantable Pulse Generator Models 3660 3661 3662 3663 3665 3667 Clinician s Manual ...

Page 2: ...e oxide which is known to the State of California to cause cancer and birth defects or other reproductive harm For more information go to www P65Warnings ca gov Indicates a trademark of the Abbott group of companies Indicates a third party trademark which is property of its respective owner Pat http www abbott com patents 2019 Abbott All Rights Reserved ...

Page 3: ...ials 13 IPG Specifications 14 Compatibility Guidelines for IPGs with Compatible Headers 15 Appendix B System Components and Accessories 16 IPGs 16 Programmers and Controllers 16 Leads and Extensions 16 Adapters 17 Trial System 17 Appendix C Battery Longevity Information 18 Energy Factors for Tonic Stimulation Parameters 19 Energy Factors for BurstDR Stimulation Parameters 23 Battery Longevity Grap...

Page 4: ...i Appendix E Safety and Effectiveness Studies 29 Clinical Summary for the Genesis IPG Neurostimulation System for SCS 29 Clinical Summary for BurstDR Stimulation 32 Appendix F Symbols and Definitions 73 ...

Page 5: ...s available online at medical abbott manuals For more information about MR Conditional products visit the Abbott Medical product information page at neuromodulation abbott MRI ready Warnings The following warnings apply to this neurostimulation system Poor surgical risks Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active genera...

Page 6: ...mize or prevent the implanted cardiac system from sensing the output of the neurostimulation system 1 maximize the distance between the implanted systems 2 verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system and 3 avoid programming either device in a unipolar mode using the device s can as an anode or using neurostimulation system settings ...

Page 7: ...s well as other potentially hazardous materials Do not crush puncture or burn the IPG because explosion or fire may result Product materials Neurostimulation systems have materials that come in contact or may come in contact with tissue A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted Precautions The following pre...

Page 8: ...ave been sterilized using ethylene oxide EtO gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field Do not resterilize or reimplant an explanted system for any reason Storage environment Store components and their packaging where they will not come in contact with liquids of any kind Handling and Implementation Expiration date An expiration d...

Page 9: ...eening devices may affect stimulation Additionally RFID devices which are often used to read identification badges as well as some tag deactivation devices such as those used at payment counters at stores and loan desks at libraries may also affect stimulation Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a mo...

Page 10: ...rebrospinal fluid CSF leakage Paralysis weakness clumsiness numbness or pain below the level of the implant Persistent pain at the electrode or IPG site Seroma mass or swelling at the IPG site Allergic or rejection response to implant materials Implant migration or skin erosion around the implant Battery failure System Overview This neurostimulation system is designed to deliver electrical stimula...

Page 11: ...ge sizes to accommodate different power needs Some models support additional functions Upgradeability Models can receive software upgrades after implantation to provide patients with additional features as approved by the respective regulatory agencies To upgrade features on the IPG a system programmer is needed Compatible header Models with a compatible header are designed to allow the IPG to con...

Page 12: ...ed use the clinician programmer app to communicate with the IPG and view IPG information See the clinician s manual for the clinician programmer for instructions Figure 2 Location of the IPG code on a small IPG left and large IPG right Directions for Use Read this section carefully for suggested directions for use related to the IPG For directions for use for other system components not covered in...

Page 13: ...ely 2 To help ensure that the lead or extension can be fully inserted into the IPG header insert the torque wrench through the septum on the IPG header turn the torque wrench clockwise to tighten the setscrew until the torque wrench clicks and then loosen the setscrew again by turning the wrench counterclockwise about 2 5 times CAUTION Use only the torque wrench included in the extension IPG or to...

Page 14: ...tension IPGs with compatible header Fully inserted 1 Window between each header contact is clear 2 Eighth contact band is not visible Not fully inserted 3 Window between each header contact is partially blocked by contact band 4 Eighth contact band is visible 4 Use the clinician programmer app to communicate with the IPG and test the impedance to ensure that the lead or extension is fully inserted...

Page 15: ...OTE By implanting the IPG with the logo side facing the skin surface you enhance the IPG s ability to detect a magnet 2 Carefully coil any excess lead or extension behind the IPG in loops no smaller than 2 5 cm 1 in in diameter to provide strain relief for the lead or extension and IPG connection CAUTION Do not bring the suture needle in contact with an IPG lead or extension or the component may b...

Page 16: ... following sections Connecting a Lead or Extension to the IPG page 9 and Implanting the IPG page 11 Disposing of Explanted Components Explanted Abbott Medical components should be returned to Abbott Medical for proper disposal To return an explanted component place it in a container or bag marked with a biohazard label and coordinate the return with your Abbott Medical representative or Technical ...

Page 17: ...s Contact your local representative for more information Storage Specifications Store the components in this kit according to the following conditions Table 1 Storage conditions for components Temperature 20 C 60 C 4 F 140 F Product Materials The following materials are intended to come into contact with tissue Table 2 Product materials for IPG kit Component Material IPG Titanium silicone rubber P...

Page 18: ... Unsafe Yes Yes 3665 3667 MR Unsafe No No Height 5 55 cm 2 19 in 6 68 cm 2 63 in Length 4 95 cm 1 95 in 5 02 cm 1 98 in Thickness 1 34 cm 0 53 in 1 35 cm 0 53 in Weight 48 9 g 1 7 oz 58 3 g 2 1 oz Volume 30 4 cm3 1 9 in3 38 6 cm3 2 4 in3 Power source Carbon monofluoride silver vanadium oxide cell Connector strength 10 N Models 3660 3662 3665 3667 5 N Models 3661 3663 Program storage capacity 15 pr...

Page 19: ...n s programming manual for this system NOTE The number of stim sets in use for a tonic program governs the maximum frequency 1200 number of stim sets NOTE The maximum current depends on the impedance frequency and pulse width settings Compatibility Guidelines for IPGs with Compatible Headers IPGs with compatible headers are compatible with the following Medtronic leads and extensions available bef...

Page 20: ...im 7 implantable pulse generator 3665 Proclaim 5 implantable pulse generator 3667 Proclaim 7 implantable pulse generator IPG Accessories 1101 Torque wrench 1111 Port plug Programmers and Controllers 3874 St Jude Medical Clinician Programmer App 3875 St Jude Medical Patient Controller App Programmer and Controller Accessories 1210 Patient magnet 3884 SCS patient manual and magnet Leads and Extensio...

Page 21: ...6 8 channel adapter M 60 cm Trial System 3599 St Jude Medical External Pulse Generator Trial System Accessories 1203 Cleaning cloths 1212 Coin cell batteries 1213 Pouch with adhesive 5 1214 Pouch without adhesive and belt 5 1216 EPG header cap 1218 Carrying case 1917 Battery door 3013 Multilead trial cable 3032 External pulse generator 2 port header ...

Page 22: ...stimulation parameters according to the lead impedance in the tables in one of the following sections For IPGs using tonic stimulation parameters see Energy Factors for Tonic Stimulation Parameters page 19 For IPGs using BurstDR stimulation parameters see Energy Factors for BurstDR Stimulation Parameters page 23 NOTE If the desired parameters do not appear in the tables estimate the energy factor ...

Page 23: ...parameters 350 ohm impedance Pulse Width µs Amplitude mA Frequency Hz 100 200 300 500 30 13 14 14 15 1 60 18 19 20 23 90 22 24 26 29 30 15 17 20 24 2 60 21 26 30 40 90 27 34 41 54 30 16 19 23 30 3 60 24 30 37 51 90 30 41 51 71 30 17 22 26 47 4 60 26 35 44 85 90 34 47 61 122 30 21 30 38 55 5 60 34 51 68 102 90 46 71 97 148 30 23 33 43 81 6 60 37 58 78 152 90 51 81 112 223 30 29 44 60 92 7 60 49 80 ...

Page 24: ...7 34 41 54 30 16 19 23 38 3 60 24 30 37 68 90 30 41 51 97 30 19 26 33 47 4 60 31 44 58 85 90 41 61 82 122 30 24 35 47 69 5 60 40 62 85 130 90 54 88 122 190 30 26 40 54 81 6 60 44 71 98 152 90 61 102 142 274 30 33 52 72 111 7 60 57 96 135 214 90 80 139 198 317 30 35 58 94 148 8 60 62 107 180 288 90 88 156 264 426 30 43 74 104 190 9 60 78 139 200 372 90 112 203 294 554 30 53 92 131 210 10 60 96 175 ...

Page 25: ...1 54 30 18 23 28 38 3 60 27 37 48 68 90 36 51 66 97 30 22 31 40 58 4 60 35 53 71 107 90 47 75 102 156 30 24 41 55 83 5 60 40 73 102 158 90 54 105 148 232 30 30 47 63 114 6 60 51 85 119 220 90 71 122 173 325 30 37 60 84 151 7 60 65 112 159 294 90 92 163 234 436 30 45 76 108 197 8 60 81 144 207 382 90 116 211 305 566 30 58 98 139 220 9 60 103 184 265 427 90 147 269 390 710 30 62 119 169 271 10 60 11...

Page 26: ...2 30 20 26 33 47 3 60 31 44 58 85 90 41 61 81 122 30 24 35 47 69 4 60 40 62 85 130 90 54 88 122 190 30 30 47 64 98 5 60 51 85 119 186 90 72 122 173 275 30 37 60 84 131 6 60 65 112 160 292 90 92 163 234 431 30 49 80 112 195 7 60 85 148 211 377 90 120 215 345 558 30 58 98 139 243 8 60 103 184 293 473 90 148 269 432 702 30 68 119 185 297 9 60 124 225 358 580 90 178 362 529 939 30 80 153 221 356 10 60...

Page 27: ...Dosage On Time Off Time Continuous Dosage 5 s 15 s 15 s 45 s 30 s 90 s 60 s 180 s 30 s 150 s 30 s 180 s 30 s 360 s 0 2 47 31 25 23 16 13 7 77 0 4 71 43 34 28 20 17 10 89 0 6 93 53 41 34 24 20 12 104 0 8 117 65 49 40 29 25 13 118 1 0 146 76 56 46 34 28 16 134 1 2 175 106 84 73 50 42 24 240 1 4 202 121 95 82 56 48 26 270 1 6 230 135 106 91 63 55 29 301 1 8 247 151 120 100 70 60 33 330 2 0 279 163 13...

Page 28: ...1 6 239 159 132 115 80 68 36 417 1 8 271 179 149 132 88 75 41 465 2 0 299 195 164 146 97 83 44 509 Table 13 Energy factors for various BurstDR stimulation parameters 1000 ohm impedance Amplitude mA Intermittent Dosage On Time Off Time Continuous Dosage 5 s 15 s 15 s 45 s 30 s 90 s 60 s 180 s 30 s 150 s 30 s 180 s 30 s 360 s 0 2 48 32 26 23 15 13 7 77 0 4 71 43 34 29 20 17 10 93 0 6 100 64 51 45 30...

Page 29: ...ls 3662 3663 and 3667 The following figure shows the estimated longevity of an IPG battery after the low battery warning also called the elective replacement indicator ERI first appears on the clinician programmer app or patient controller app when the battery is approaching its end of service Figure 8 Estimated battery longevity by energy factor for Proclaim IPGs from time of ERI 1 Estimated batt...

Page 30: ... particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an o...

Page 31: ...16 3 µA m Electric field strength at 2 m distance 6 1 mV m Output power EIRP 1 mW 0 dBm typical 10 mW 10 dBm maximum Range 1 2 m typical Center frequency 2 44 GHz Channel 40 logical channels Bandwidth 2 MHz per channel Data flow Bi directional Protocol Bluetooth Smart wireless technology EIRP Equivalent isotropically radiated power Radio Transmitter Cables Transducers The device contains a radio t...

Page 32: ... that need to be transmitted i e if there is only one packet to transmit only one packet will be transmitted If the interference is high e g the bit error rate exceeds 0 1 the user may experience what appears to be a slow connection difficulty pairing devices and a need to decrease the distance between connected devices For information on how to improve connection issues please refer to Troublesho...

Page 33: ...in associated with the following failed back surgery syndrome and intractable low back and leg pain Efficacy Evaluation Three clinical literature studies were used to assess the safety and effectiveness of the Genesis IPG neurostimulation system Ohnmeiss et al 1996 Villavicencio et al 2000 Hassenbusch SJ et al 1995 The studies included a total of 116 patients that were implanted with an SCS system...

Page 34: ...eral or bilateral leg pain treated over a 5 year period The study was a comparison of SCS to spinal infusion of opioids For patients with radicular pain involving one leg with or without unilateral buttock pain a trial of SCS was recommended first For patients with midline back pain and or bilateral leg pain a trial of long term spinal infusion was recommended first If the patients failed screenin...

Page 35: ...her 1059 24 2 3 References 1 Broggi G Servello D Dones I Carbone G Italian multicentric study on pain treatment with epidural spinal cord stimulation Stereotact Funct Neurosurg 62 1994 273 278 2 Burchiel KJ Anderson VC Brown FD et al Prospective multicenter study of spinal cord stimulation for relief of chronic back and extremity pain Spine 21 1996 2786 2793 3 Devulder J De Laat M Van Basterlaere ...

Page 36: ...med a clinical study to establish reasonable assurance of safety and effectiveness of BurstDR stimulation for the treatment of chronic intractable pain of the trunk and or limbs The following sections present information and results for the SUNBURST study SUNBURST Study Design Subjects began to enroll in the study in January 2014 and treatment has continued through the time of this report This rep...

Page 37: ...teria Subjects were limited to those who met all of the following criteria Subject signed an informed consent to participate in the study Subject was at least 22 years old Subject had chronic intractable pain of the truck and or limbs Subject scored a baseline average of 60 or higher for average daily overall pain on the visual analog scale VAS 7 day pain diary Subject tried best medical therapy b...

Page 38: ... had an impaired immune system immunocompromised Subject had a documented history of an allergic response to titanium or silicone Subject had a documented history of substance abuse with substances such as narcotics or alcohol or substance dependency within 6 months of the collection of baseline data Subject was a female of childbearing potential who was pregnant confirmed by a positive urine or b...

Page 39: ...ient satisfaction with the device Stimulation mode preference tonic or burst Patient Global Impression of Change PGIC Comparison of the quality of life in physical and mental components of Short Form 36 SF 36 Comparison of function in the Oswestry Disability Index ODI version 2 1a Pain quality as assessed by the Short Form McGill Pain Questionnaire SF MPQ 2 Pain catastrophizing as assessed by the ...

Page 40: ...imulation After the SCS trial evaluation 101 subjects met the standard criteria for success and were implanted with the Prodigy neurostimulation system Of these 101 subjects 100 were randomized and activated The final subject was randomized in August 2015 A total of 96 subjects completed the week 24 follow up visit for the primary endpoint The following figure summarizes the accounting for study s...

Page 41: ... p value Age Mean SD 59 1 13 5 141 58 8 13 6 45 60 4 13 4 55 0 562t Minimum Median Maximum 25 0 60 0 88 0 27 0 62 0 88 0 25 0 61 0 84 0 Gender n N Female 85 141 60 3 26 45 57 8 31 55 56 4 0 887c Male 56 141 39 7 19 45 42 2 24 55 43 6 Weight lb Mean SD 191 7 48 0 141 189 0 42 8 45 195 31 47 1 55 0 509t Minimum Median Maximum 85 0 190 0 350 0 85 0 184 0 340 0 113 0 193 0 289 0 Height in Mean SD 66 7...

Page 42: ...2 45 4 4 7 55 12 7 Diagnosis n N Arachnoiditis 1 141 0 7 1 45 2 2 0 55 0 0 0 189f CRPS I CRPS II 2 141 1 4 0 45 0 0 2 55 3 6 Degenerative spine disease 7 141 5 0 1 45 2 2 2 55 3 6 Failed back surgery syndrome FBSS 59 141 41 8 15 45 33 3 27 55 49 1 Neuritis neuropathy neuralgia 3 141 2 1 0 45 0 0 2 55 3 6 Postoperative chronic pain 5 141 3 5 1 45 2 2 2 55 3 6 Radiculopathies 52 141 36 9 21 45 46 7 ...

Page 43: ...urgery 13 141 9 2 3 45 6 7 7 55 12 7 Other 11 141 7 8 5 45 11 1 4 55 7 3 Unknown 72 141 51 1 23 45 51 1 26 55 47 3 w Wilcoxon rank sum test f Fisher s exact test Table 19 Pain treatment history Randomization Pain History Subjects with Baseline Visit N 141 Arm 1 Tonic Burst N 45 Arm 2 Burst Tonic N 55 p value Non Invasive Interventions Oral medications 137 141 97 2 43 45 95 6 54 55 98 2 0 587f Phys...

Page 44: ... 8 0 615c Botulinum toxin 3 141 2 1 0 45 0 0 3 55 5 5 0 250f Radiofrequency denervation 33 141 23 4 10 45 22 2 9 55 16 4 0 458c Intradiscal electrothermal therapy IDET 0 141 0 0 0 45 0 0 0 55 0 0 Percutaneous intradiscal radiofrequency thermocoagulation 0 141 0 0 0 45 0 0 0 55 0 0 Local anesthetic injections tender or trigger point injections 28 141 19 9 7 45 15 6 10 55 18 2 0 728c Other 30 141 21...

Page 45: ...cedure related No unanticipated adverse device affects UADEs were reported during the study Both study related and non study related adverse events were collected and monitored through long term study visits up to 24 months or until study completion A total of 158 AEs were reported during the study 97 59 5 of which were considered to be non study related Twenty one 21 events were considered SAEs a...

Page 46: ...related SAEs Event Description Number of Events Number of Subjects Percent of Subjects n N Enrollment to activation Persistent pain and or numbness 1 1 0 58 1 173 Unsuccessful lead placement 1 1 0 58 1 173 Total 2 2 1 16 2 173 Subjects at risk out of subjects enrolled in study The following table shows SAEs that were unrelated to the study Nineteen 19 events were reported in 15 subjects 8 7 Thirte...

Page 47: ...1 1 1 00 1 100 c Somnolence sleepiness 1 1 1 00 1 100 c Temporary paralysis 1 1 1 00 1 100 c Withdrawal symptoms from tapering off of oxymorphone 1 1 1 00 1 100 c Total 19 15 8 67 15 173 The generic name of the medication oxymorphone is used instead of the brand name Some subjects experienced more than one event therefore the number of subjects experiencing an event is not equal to the number of e...

Page 48: ...d pain 1 1 1 00 1 100 a Infection 2 2 2 00 2 100 a Local skin erosion 1 1 1 00 1 100 a Persistent pain and or numbness 6 6 6 00 6 100 a Postoperative low back pain 1 1 1 00 1 100 a Seroma at the implant site 1 1 1 00 1 100 a Stimulation in wrong place 6 4 4 00 4 100 a Unpleasant sensations 7 6 6 00 6 100 a Weakness 3 3 3 00 3 100 d Total 62 31 31 00 31 100 Undesirable changes in stimulation Uninte...

Page 49: ... Diminished or loss of symptom relief 8 6 6 19 6 97 b Stimulation in wrong place 5 4 4 12 4 97 b Unpleasant sensations 1 1 1 03 1 97 b Total 29 16 16 00 16 100 Undesirable changes in stimulation Unintended effects of stimulation Some subjects experienced more than one event therefore the number of subjects experiencing an event is not equal to the number of events in the neighboring column The tot...

Page 50: ...domized subjects N 100 Surgery Arm 1 Tonic Burst N 45 Arm 2 Burst Tonic N 55 Number of leads implanted Mean SD N 1 8 0 7 45 1 7 0 8 55 Minimum Median Maximum 1 0 2 0 4 0 1 0 2 0 4 0 1 lead 16 45 35 6 22 55 40 0 2 leads 26 45 57 8 27 55 49 1 3 leads 1 45 2 2 4 55 7 3 4 leads 2 45 4 4 2 55 3 6 IPG placement side Left 39 45 86 7 44 55 80 0 Right 6 45 13 3 11 55 20 0 IPG anatomic location Abdomen 1 45...

Page 51: ... 0 5 0 6 343 1 6 1 0 347 2 7 0 8 346 Minimum 0 0 0 1 Maximum 1000 2 5 5 Recharging data were collected at follow up visits including unscheduled programming visits The following table shows a summary of recharging information through 24 weeks Recharging instructions for routine care of a typical neurostimulation system using tonic stimulation were given at the discretion of the investigator thus n...

Page 52: ... 78 57 Frequency Daily 1 15 6 67 0 22 0 0 2 3 times a week 4 15 26 7 3 22 13 6 Weekly 8 15 53 3 17 22 77 3 Every other week 1 15 6 67 2 22 9 09 Once a month or less often 1 15 6 67 0 22 0 0 Reason Low battery message 3 15 20 0 4 22 18 2 Normal routine 10 15 66 7 15 22 68 2 Patient checks battery and charges when less than 50 depleted 1 15 6 67 0 22 0 0 Recommended time frame 1 15 6 67 3 22 13 6 We...

Page 53: ...ime frame 1 11 9 09 0 7 0 0 SUNBURST Study Results This section provides results from the SUNBURST study Primary Effectiveness The analysis of effectiveness was an intention to treat analysis based on the randomization population of 100 subjects Statistical methods were used to impute VAS scores for the following subjects and reasons Six 6 subjects increased pain medication in during the 12 weeks ...

Page 54: ... non inferiority margin of 7 5 Additionally the p value for the test of the non inferiority hypothesis was 0 001 Therefore the primary endpoint was met and it is concluded that burst stimulation is non inferior to tonic stimulation Table 28 Primary endpoint overall VAS score Randomization Arm 1 tonic burst Arm 2 burst tonic Pooled Burst Mean SD N 42 7 26 1 45 44 2 25 3 55 43 5 25 6 100 Minimum Med...

Page 55: ...aximum 1 0 49 3 88 1 0 0 49 3 98 7 Burst Tonic Mean SD N 3 6 26 3 45 6 5 21 0 55 Minimum Median Maximum 64 6 3 7 79 0 70 4 2 6 48 4 Burst Tonic Average Pooled SD Across Arms 5 1 11 8 95 UCB on Difference Burst Tonic 1 14t Superiority Margin 0 p value for Superiority Test 0 017t Endpoint Met Yes t 95 UCB and p value for superiority are based on a t distribution with n1 n2 2 degrees of freedom where...

Page 56: ...tion A cross tabulation of responders for burst stimulation versus tonic stimulation shows numerically more subjects whose VAS score decreased by at least 30 with burst stimulation than with tonic stimulation 18 versus 9 However this difference was not statistically significant p 0 083 Table 30 Responder rates decrease of 30 from baseline for overall daily VAS score Overall Responder Rate Percent ...

Page 57: ... figure the responder rate was defined as a 30 or more reduction in the overall VAS score Figure 11 Percentage reduction 30 responder rate in overall VAS score from baseline by stimulation mode The following figure shows the percentage of pain relief from burst stimulation left graph and tonic stimulation right graph in the individual subjects for week 12 using a responder rate definition of 30 ...

Page 58: ...e in overall VAS score at week 12 from baseline The following figure shows the percentage of pain relief from tonic stimulation left graph and burst stimulation right graph in the individual subjects for week 24 using a responder rate definition of 30 ...

Page 59: ...cts 65 73 experienced a reduction in paresthesia or no paresthesia with burst stimulation compared to tonic stimulation The following table summarizes these results Table 31 Summary of paresthesia mapping with burst and tonic stimulation Cross Tabulation of Paresthesia by Stimulation Mode Stimulation mode Tonic Paresthesia No Yes Overall Burst No 2 73 2 7 45 73 61 6 47 73 64 4 Yes 0 73 0 0 26 73 3...

Page 60: ...he following data consist of descriptive secondary and additional endpoints that were predetermined within the clinical study protocol See Clinical Endpoints page 34 Additional descriptive nonpowered data have also been provided Pain Measures The FDA requested analyses to be performed on overall pain trunk and limb VAS pain measures from baseline to 12 weeks Because the study had a crossover desig...

Page 61: ...ore from baseline with burst and tonic stimulation A total of 49 subjects 49 responded to tonic stimulation burst stimulation or both The overall VAS scores decreased by at least 50 for more subjects with burst stimulation than with tonic stimulation 17 versus 10 Table 34 Responder rates decrease of 50 from baseline for overall daily VAS score Overall Responder Rate Burst subjects n N 39 100 39 0 ...

Page 62: ...s figure the responder rate was defined as a 50 or more reduction in the overall VAS score Figure 14 Percentage reduction 50 responder rate in overall VAS score from baseline by stimulation mode The following figure shows the percentage of pain relief from burst stimulation left graph and tonic stimulation right graph in the individual subjects at week 12 using a responder rate definition of 50 ...

Page 63: ...te in overall VAS score at week 12 from baseline The following figure shows the percentage of pain relief from burst stimulation left graph and tonic stimulation right graph in the individual subjects at week 12 using a responder rate definition of 50 ...

Page 64: ...50 while using burst stimulation than while using tonic stimulation 39 versus 32 and fewer subjects experienced reduction in overall VAS score by 30 while using burst stimulation 40 versus 49 Table 35 Summary of decrease in overall VAS score from baseline by three categories Decrease in Overall VAS From Baseline Burst Tonic Arm 1 Tonic Burst 30 18 45 40 0 21 45 46 7 30 50 10 45 22 2 8 45 17 8 50 1...

Page 65: ... were lower than those during tonic stimulation by 5 7 Average changes for trunk VAS scores for baseline to week 12 are also lower for burst stimulation by 8 9 Table 36 Summary of trunk VAS scores Randomization Arm 1 tonic burst Arm 2 burst tonic Pooled Burst Mean SD N 39 7 25 3 45 41 8 25 8 55 40 9 25 5 100 Minimum Median Maximum 0 6 38 0 85 4 0 0 40 6 99 0 Tonic Mean SD N 44 2 21 9 45 48 8 25 6 ...

Page 66: ...omplete data show that limb VAS scores for burst stimulation were lower than those during tonic stimulation by 4 7 Average changes for limb VAS scores for baseline to week 12 are also lower for burst stimulation by 5 8 Table 38 Summary of limb VAS scores Randomization Arm 1 tonic burst Arm 2 burst tonic Pooled Burst Mean SD N 37 2 27 8 44 35 9 27 1 54 36 5 27 3 98 Minimum Median Maximum 0 7 38 2 1...

Page 67: ...marizes worst VAS scores for the randomization subject population The data shows that burst stimulation worst VAS scores were lower than those during tonic stimulation by 4 1 points Table 40 Summary of worst VAS scores Randomization Arm 1 tonic burst Arm 2 burst tonic Pooled Burst Mean SD N 52 2 27 9 45 52 3 26 9 55 52 3 27 2 100 Minimum Median Maximum 0 4 54 4 100 0 0 0 50 1 97 7 Tonic Mean SD N ...

Page 68: ...pable of both stimulation modes Table 41 Subject satisfaction summary at week 24 Satisfaction Level Burst Tonic Burst subjects n N 85 96 88 5 82 96 85 4 Tonic subjects n N 11 96 11 5 14 96 14 6 Difference in satisfaction rate burst tonic 3 1 95 CI of difference in satisfaction rate lower bound upper bound 5 3 11 5 Cross Tabulation of Satisfaction Level by Stimulation Mode Stimulation mode Tonic Sa...

Page 69: ...e a real and worthwhile difference 35 97 36 1 43 96 44 8 A great deal better and a considerable improvement that has made all the difference 17 97 17 5 12 96 12 5 The following table presents the physical and mental component scores for the SF 36 quality of life survey Burst stimulation had higher pooled scores than tonic stimulation with a difference of 0 4 for the physical component score and 0 ...

Page 70: ...e Pooled SD Across Arms 0 4 3 6 95 CI 1 1 1 9 Mental Component Scores Baseline Mean SD N 47 1 12 9 42 50 2 11 6 47 48 7 12 3 89 Minimum Median Maximum 18 6 48 4 71 4 24 5 54 4 69 5 Burst Mean SD N 50 2 12 6 42 52 3 9 6 47 51 3 11 1 89 Minimum Median Maximum 16 1 50 9 72 5 31 2 56 2 68 6 Tonic Mean SD N 49 1 11 9 42 52 0 9 8 47 50 6 10 9 89 Minimum Median Maximum 19 3 49 6 67 7 25 6 53 5 64 2 Burst...

Page 71: ... 48 9 11 3 45 49 2 10 6 50 49 1 10 9 95 Minimum Median Maximum 24 0 50 0 80 0 17 8 50 0 72 0 Burst Mean SD N 33 4 16 9 45 37 5 15 6 50 35 6 16 3 95 Minimum Median Maximum 0 0 32 0 80 0 4 0 41 0 70 0 Tonic Mean SD N 34 4 15 3 45 36 5 14 3 50 35 5 14 8 95 Minimum Median Maximum 0 0 34 0 74 0 0 0 37 9 72 0 Burst Tonic Mean SD N 1 0 12 5 45 1 0 11 8 50 Minimum Median Maximum 28 0 2 0 40 0 24 0 2 0 44 ...

Page 72: ... reduced the PCS score however neither produced clinically meaningful changes on the PCS Again the reason for this observation may be the relatively low baseline scores observed in the study population The average baseline PCS score of 20 4 was well below what is considered to reflect a clinically relevant level of pain catastrophizing which is a score that is more than 30 Sullivan 2009 Table 47 S...

Page 73: ...rved under both stimulation modes at follow up The BDI II scores may have remained the same because those subjects with clinically significant depression symptoms were excluded from the study Further an improvement from minimal depression symptoms would not necessarily be expected The following table shows a summary of BDI II scores Table 48 Summary of BDI II scores Randomization Arm 1 tonic burst...

Page 74: ...y supervised treatments Conclusions Drawn from the Study This section provides study conclusions based on stimulation effectiveness safety and risks and benefits as well as overall conclusions Effectiveness Conclusions This section provides conclusions on stimulation effectiveness Pain measures The primary effectiveness endpoint of non inferiority was met 43 5 versus 48 7 p 0 001 and burst stimula...

Page 75: ... any events categorized as unanticipated adverse device effects UADEs were reported during the study Fewer stimulation related events occurred during burst stimulation than tonic stimulation 13 events in 11 subjects and 16 events in 10 subjects respectively Benefit Risk Conclusions The probable benefits of the device are based on this clinical study for burst stimulation Effectiveness was demonstr...

Page 76: ...Renier CM Palcher JA Chronic pain depression and quality of life correlations and predictive value of the SF 36 Pain Med 2003 4 4 331 339 5 Kumar K Taylor R Jacques L et al Spinal cord stimulation versus conventional medical management for neuropathic pain a multicentre randomised controlled trial in patients with failed back surgery syndrome Pain 2007 132 1 2 179 188 6 May WL Johnson WD Confidenc...

Page 77: ... magnetic field the switched gradient magnetic field and the radiofrequency fields Additional conditions including specific configurations of the item may be required Magnetic Resonance MR Unsafe an item poses unacceptable risks to the patient medical staff or other persons within an MR environment Device contains a radio frequency RF transmitter which may cause RF interference with other devices ...

Page 78: ...RE directive 2014 53 EU Annex II Hereby Abbott Medical declares that this device complies with the essential requirements and other relevant provisions of these directives The full text of the European Union RE directive 2014 53 EU declaration of conformity is available at the following internet address www neuromodulation abbott euconformity Australian Communications and Media Authority ACMA and ...

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Page 80: ...Medical 6901 Preston Road Plano Texas 75024 USA 1 855 478 5833 1 651 756 5833 Abbott Medical The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium 32 2 774 68 11 2019 09 ARTEN600060791 A 600060791 ...

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