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

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download