SUMMARY OF SAFETY AND PROBABLE BENEFIT …
SUMMARY OF SAFETY AND PROBABLE BENEFIT
1.
GENERAL INFORMATION
DeviceGeneric Name:
Gastricelectricalstimulator
DeviceTrade Name:
EnterraTm
TherapySystem
Applicant's Name and Address:
Medtronic, Inc.
NeurologicalDivision
80053 d AvenueNE
Minneapolis,Minnesota 55421
Humanitarian DeviceExemption (HDE) Number:
H990014
Date of Humanitarian UseDeviceDesignation:
September23, 1999
Date of PanelRecommendation:
The EnterraTmTherapySystemwasnot submittedto the Gastroenterology
andUrology
DevicesPanelfor review(refer to SectionXI for discussion).
Date of Good Manufacturing Practices Inspection:
Each manufacturingsite andthe date of the most recentinspectionat eachis listed below:
MedtronicMedRel - -Humacoa;
PuertoRico - November 1998
MedtronicMilaca - Milaca, Minnesota- November1998
MedtronicB.V. - Kerkrade,The Netherlands- February1997
MedtronicNeurological- Minneapolis,Minnesota- January1999
Date of Notice of Approval to Applicant:
11.
March 31,2000
INDICATIONS FOR USE
The EnterraTm
TherapySystemis indicatedfor thetreatmentof chronic, intractable(drug
nausea
and vomiting secondaryto gastroparesis
of diabetic or idiopathicetiology.
refractory)
111.
DEVICE DESCRIPTION
The EnteffaTmTherapySystemis an implantedgastric stimulationsystemthat consistsof these
components:the implantedpulsegenerator(Model 7425GNeurostimulator),two unipolar
intramuscularstomachleads(Model 4301 Lead),the stimulatorprogrammer(Model 7432
PhysicianProgrammer),andthe memory cartridge(Model 7457MemoryMod Software
Cartridge).
The implantablepulsegenerator,stimulatorprogrammer,andmemory cartridgewerepreviously
approvedfor marketingunderPremarketApproval Application P840001/S37.The Model 4301
Lead is the only componentof the EnteffaTmTherapySystemthat has not beenapprovedor
clearedundera prior marketingapplication,althoughit is similar in designandfeaturesto other
previously approvedleadsfor stimulation.
The Model 7425GNeurostimulatoris renamedfrom the Model 7425Itrel III implantedpulse
generator.Similarly, the Model 4301 Leadis renamedfrom the Model 4300 Lead. The earlier
versionof eachcomponentwasusedin the WAVESS clinical studydescribedin SectionIX of
this summary. All componentsare identicalin termsof materials,engineering,and technical
specifications,with the only changebeing the devicename.
The intramuscularstomachleads,implantedvia laparoscopy,areplacedon the greatercurvature
of the stomach. The implantedpulsegenerator(IPG) is implantedin a subcutaneous
pocket,
createdin the abdominalarea,and is then connectedto the leads. The IPGprovides -generally
the energysourcethat deliverstheelectricalpulseto the stomachmusclethroughthe stomach
leads.
Via the stimulator programmer,the IPG stimulatesthe stomachmuscleat a setof stimulation
parametersdeterminedby the physician. Thedefault parameters,usedin the clinical studies
describedin SectionIX, are asfollowsamplitude:
pulsewidth:
frequency:
cycle ON time:
cycle OFF time:
IV.
5 mA
330 Vsec
14Hz
0.1 sec
5.0 sec
CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS
Contraindications
This deviceis contraindicatedin patientswhom the physiciandeterminesis not acandidatefor
surgicalproceduresand/oranesthesiadueto physical or mentalconditions.
Warnings and Precautions
Thewarningsand precautionscanbe foundin the PhysicianLabelingattached.
Page2 - MedtronicEnterraTm
TherapySystem
- SummaryofSafetyandProbable
H990014
Benefit
V.
ADVERSE EFFECTS OF THE DEVICE ON HEALTH
of diabeticor
Adverseeffectsdatawerecollectedon patientswith drug-refractorygastroparesis
idiopathicetiologiesin two clinical studiesconductedin theUnited States,Canada,andEurope.
Thetable below summarizesthoseadverseeventsreportedthroughSeptember30, 1999.
Table I - Summary of Adverse Events (N = 51)
Event
# Events
Device-or Implant-Related
outof range
7
Leadimpedance
2
Deviceinfections
Deviceerosion
Devicemigrations
2
4
1
Stomachwall perforation
UnderlyingDisease-Related
UpperGI symptoms
81
Extraabdominal
pain
33
23
Feedingtubecomplications
LowerGI symptoms
17
Dehydration
15
Boneandjoint related
11
9
Acutediabeticcomplications
Dysphagia
5
Cardiovascular/renal
related
2
OtherTherqpyComplications
23
Feedingtubeor IV complications
Miscellaneous
4
Urinarytractinfections
Stressincontinence
2
Fever
6
Otherinfections:
3
pink
herpes
zoster
sinus,
eye,
NPatients
%of Patients
6
2
1
1
1
12
4
2
2
2
23
14
14
9
8
8
6
1
2
45
27
27
20
16
16
12
2
4
14
27
4
2
4
3
8
4
8
6
I . Thedevicesystemwasremoved
in bothpatients;
a new systemwassubsequently
implanted
in oneof thesepatients.
2. The devicesystemwasremovedin onepatient;a new systemwassubsequently
implanted.
3. The devicesystemwastwicesurgically
revised,butnotremoved,in thesamepatient.
4. The devicesystemwasremovedandnotre-implanted
or replacedwitha newsystem.
Threetypesof devicerelatedadverse
eventsrequiredsurgicalintervention.Theseeventswere
=
deviceinfection(N 3), stomach
wall perforation
(N = 1) andmigrationof thepulsegenerator
=
(N 1).
EnterraTm
Page3 - Medtronic
System
Therapy
- Summary
H990014
ofSafety
andProbable
Benefit
Other Potential Risks
The implantationand/oruseof the EnterraTm
TherapySystemcarriesotherpotentialrisks, which
below:
are described
undesirablechangein stimulation,possiblyrelatedto cellular changesaroundthe
electrodes,shifts in electrodeposition,looseelectrical connections,or leadfractures;
2.
hemorrhage,hematoma,andpossibleGI complicationsresultingfrom the surgical
procedureto implantthepulsegeneratorand leads;
3.
persistentpain at the pulsegeneratorsite;
4.
seromaat thepulse generatorsite;
5.
allergenicor immunesystemresponse
to theimplantedmaterials;
and
6.
lossof therapeutic
effect.
VI.
ALTERNATIVE PRACTICES AND TREATMENTS
is a debilitatingdisease
in whichpatientssufferfroma numberof upperGI
Gastroparesis
symptoms
fullness,epigastric
includingnausea,vomiting,earlysatiety,bloating,postprandial
painandburning,andcardiacpainandburning.Severesymptoms,
particularlyvomitingand
can
impair
a
patients
activities
and
nausea, significantly
daily
qualityof life.
Currentmedicalpracticeforthetreatmentand/ormanagement
of gastroparesis
consists
of
modificati
enteralfeeding,parenteral
dietary
feedingandsurgery.These
'ons,drugtherapies,
fbr-somepatients,
aresuc-cessfut
buthave-significant
treatments
drawbacks.
KendaI12
The treatmentcontinuum
for gastroparesis
described
is illustrated
in thefigure
by
below. Patientsmayinitiallybetreatedwith variousdietarymodifications
includingfrequent
low fatmeals. However,if dietarymodifications
aloneareunsuccessful,
antiemetic
and
prokineticdrugs,or combinations
are
tried.
If
symptoms
cannot
be
controlled
thereof, generally
with medication,
supplemental
nutritionvia enteralor parenteral
feedingmayberequiredto
maintainhydrationandnutritionalstatus.
EnterraT'"
Page4 - Medtronic
System
Therapy
- Summary
H990014
ofSafety
andProbable
Benefit
Figure I - Treatment Continuum for Chronic Nauseaand
1993)2
Vomiting Secondaryto Gastroparesis(Kendall,
TreatmentOption
LeastInvasive/Risky
Dietary Modifications
Drug'fherapies
EnteralFeeding
SurgicalProcedures
Most Invasive/Risky
Total ParentalNutrition
Prokineticdrugs are intendedto promotegastricmotility, i.e., to return abnormallyslow gastric
drugsare intendedto alleviatesymptomsof nauseaand
emptying statesto normal. Antiemetic;
Motility.3
but
have
no
effect
on
vomiting,
Table 2a - Frokinetic
Prokinetic Agents
Generic Name
I
Cisapride
Bethanechol
Metoclopramide
Domperidone
I
Table 2b - Antiemetic Drugs
Antiemetic Agents
Generic Name
Meto7lopramideHCI
GranisetronHCI
OndansetronHCI
Dimenhydrinate
DiphenhydramineHCI
Prochlorperazine
PromethazineHO
ThietylperazineMalate
Trimethobenzamide
HCI
None of the prokinetic drugsare labeledfor improvedgastric emptyingin gastroparesis.
Metoclopramideis the only antierneticor prokinetic drug indicatedfor use in thetreatmentof
symptomsof diabetic gastroparesis.
Surgicalproceduresare occasionallyemployedto managesymptomsof gastroparesis
while
the
for
enteral
feeding.
Surgical
maintaining ability
procedures,including gastrectomy,
pyloroplasty,4andgastrojejunostomy,havehadlimited successin managingsymptomsof
gastroparesis.
Whendrug therapiesor surgeryare ineffective, supplementalenteralfeedingvia gastricor
jejunal feedingtubesor total parenteralnutrition (TPN) may be requiredto meetthepatient's
nutritional needs.
Page5- MedtronicEnterraTm
TherapySystem
- Summary
H990014
of SafetyandProbable
Benefit
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