Overview

1
Overview History of ICD Therapy
2
What is ICD Therapy?

• ICD Therapy consists of pacing, cardioversion,
  and defibrillation therapies to treat brady and
  tachy arrhythmias.
• An external programmer is used to monitor and
  access the device parameters and therapies for
  each patient.

3
Goals of ICD Therapy
TODAY
FUTURE

• Termination of ventricular tachycardia or
  fibrillation
• Treatment of co-morbidities of AT/AF and heart
  failure

• Prevention of life-threatening episodes of VT/VF

• Reduction of sudden cardiac death
• Improvement in quality
• of life
• Prolongation of life

• Expanding the understanding and management of
  sudden cardiac death (SCD)

4
Evolution of ICD Therapy
5
1980Large devices -Abdominal site

• First human implants
• Thoracotomy, multiple incisions
• Primary implanter cardiac surgeon
• General anesthesia
• Long hospital stays
• Complications from major surgery
• Perioperative mortality up to 9
• Nonprogrammable therapy
• High-energy shock only
• Device longevity ? 1.5 years
• Fewer than 1,000 implants/year

6
TodaySmall devices - Pectoral site

• First-line therapy for VT/VF patients
• Treatment of atrial arrhythmias
• Cardiac resynchronization therapy for HF
• Transvenous, single incision
• Local anesthesia conscious sedation
• Short hospital stays and few complications
• Perioperative mortality lt 1
• Programmable therapy options
• Single- or dual-chamber therapy
• Battery longevity up to 9 years
• More than 100,000 implants/year

7
Today Remote Follow-up is available

• Medtronic CareLink ?
• Network is the leading
• remote monitoring service
• for patients with implanted
• cardiac devices.
• Devices currently available on the Network GEM
  , GEM DR, GEM II DR/VR, GEM III DR/VR, Marquis
  DR/VR,
• Maximo DR/VR ICDs InSync ICD
• InSync Marquis CRT,
• InSync II Marquis

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Medtronic Implantable Defibrillators (1989-2003)
38 cc
39.5 cc
83 size reduction since 1989!
9
Therapies Provided by TodaysDual-Chamber ICDs

• Atrium
• AT/AF tachyarrhythmia detection
• Antitachycardia pacing
• Cardioversion

• Atrium Ventricle
• Bradycardia sensing
• Bradycardia pacing

• Ventricle
• VT/ VF detection
• Antitachycardia pacing
• Cardioversion
• Defibrillation

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GEM III AT
Total Arrhythmia Management in a Second
Generation Device

• VT/VF Detection and Therapies
• AT/AF Detection and Therapies
• AT Monitoring
• Episode Data, Marker Channel and Stored EGM
• Atrial Episode Duration Histogram
• Ventricular Rate during Atrial Episodes
• AT Intervention
• Atrial Rate Stabilization (ARS)
• Post-Mode Switch Overdrive Pacing
• AT Termination
• ATP (Ramp, Burst and 50 Hz Burst)
• Cardioversion shocks (automatic, timed and
  patient activated)
• Convenient patient management with In-Check AT
  Patient Assistant

30 Joule output 39.7 cc, 78.1 g
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Marquis Family of ICDs

• Increase Clinical Productivity
• Significant ease-of-use features
• Cardiac Compass long term trends
• Optimum Performance Package
• Best combination of output, size, longevity, and
  charge time
• Safety by Design
• Wavelet Dynamic Discrimination criterion,
  exclusive to Marquis VR
• Enhanced Dual Chamber PR Logic detection
  delivers up to 95.2 PPV
• Expanded Patient Alert Device
• Device Monitors Key Functions - Physician Manages
  Patient

Charge Time 5.9 sec BOL / 7.5
ERI Longevity 8.0 years Output 30
Joules Size 36 cc, 75 g, 13.7 mm Marquis
DR Longevity at 50 DDD Pacing, nominal cap
reformation and 2 charge/year
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InSync Marquis ICD Cardiac Resynchronization
System

• Powerful ICD Resynchronization Therapy
• Powerful 30 J therapy
• Fast charge times
• Proven cardiac resynchronization therapy for
  patients with ventricular dysynchrony
• Better, Faster Easier
• Heart Failure Patient Management
• 14 months of patient specific data provided by
  Cardiac Compass trends
• Follow up efficiency with RapidRead telemetry,
  Leadless ECG, Painless High Voltage lead
  impedance
• Implant Confidence Efficiency
• Most complete family of left-heart leads
  delivery systems
• Lead placement flexibility, enhanced telemetry
  distance, one-stop defibrillation testing

Charge Times 5.9 sec BOL / 7.5 ERI Output 30
Joules Size 38 cc, 77 g, 14 mm
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Evolution of ICD Therapy 1980 to Present
2002
2000

• MADIT-II

• ICDs with Cardiac Resynch

2004 SCD-HeFT
1997/8

• COMPANION

• Dual-Chamber ICDs
• Size Reduction
• AVID
• CASH
• CIDS

1980
1989

• First Human Implant

• Transvenous Leads
• Biphasic Waveform

1985

• FDA Approval of ICDs

1993
1999

• Smaller Devices

• AT Therapies
• MUSTT

1988
1996

• Tiered Therapy

• MADIT
• Steroid-eluting Leads
• Increased Diagnostic and
• Memory Capacity

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Future ICD Technology

• Enhanced automaticity
• Device software that suggests programming options
  to the clinician based on the patients history
  and demographics
• Continued reductions in device size
• Will require advancements in battery, capacitor
  and circuitry technology and/or decreasing the
  delivered energy output.

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Future ICD Technology

• Enhanced diagnostics
• Monitoring of the progression of both arrhythmias
  and concomitant cardiac conditions
• Enhanced lead technology
• Thinner leads with increased diagnostic
  capabilities, e.g., pressure sensing.
• Patient follow-up modifications
• Broadly available programmer technology that
  enables remote transfer of data, reducing the
  need for in-clinic visits.

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DISCLOSURE Indications/ContraindicationsMedtron
ic implantable cardioverter defibrillator (ICD)
systems are indicated to provide ventricular
antitachycardia pacing and ventricular
defibrillation for automated treatment of
life-threatening ventricular arrhythmias.
Contraindicated for patients with transient or
reversible ventricular tachyarrhythmia or as the
sole treatment of atrial arrhythmia. Medtronic
leads are designed for use with a compatible
implantable pulse generator or ICD as part of a
cardiac system. Leads are intended for
delivering therapies and/or sensing in the atrium
and/or ventricle of the heart. Contraindicated
for ventricular use in patients with tricuspid
valvular disease or a mechanical tricuspid heart
valve. Steroid eluting leads are contraindicated
in patients for whom a single dose of 1.0 mg of
dexamethasone may be contraindicated. The
Medtronic CareLink? Monitor is a prescription
device indicated for use in the transfer of
patient data from some Medtronic implantable
cardiac devices based on physician instructions
and as described in the product manual. This
product is not a substitute for appropriate
medical attention in the event of an emergency
and should only be used as directed by a
physician. Warnings/PrecautionsFor Medtronic
implantable cardioverter defibrillator systems
are Changes in patients disease and/or
medications may alter the efficacy of the
devices programmed parameters. Patients should
stay away from sources of magnetic and
electromagnetic radiation, including MRI,
diathermy, and electrosurgical units, to avoid
possible underdetection, inappropriate therapy
delivery, and/or electrical reset of the
device. Do not place transthoracic
defibrillation paddles directly over the
device. 
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For Medtronic leads are It has not been
determined whether the warnings, precautions, or
complications associated with injectable
dexamethasone apply to its use in this device.
Do not attempt to use the lead with any device
other than a commercially available implantable
defibrillator system with which it has been
tested and demonstrated to be safe and
effective. Potential ComplicationsMedtronic
implantable cardioverter defibrillator systems
include, but are not limited to, failure to
detect and/or terminate tachyarrhythmia episodes,
acceleration of ventricular tachycardia, and lead
system complications. Related to the use of
transvenous leads include, but are not limited to
the following patient- related conditions
cardiac perforation, cardiac tamponade,
constrictive pericarditis, embolism,
endocarditis, fibrillation or other arrhythmias,
heart wall rupture, hemothorax, infection,
pneumothorax, thrombosis, and tissue necrosis.
 See the technical manual for detailed uses,
indications, contraindications, warnings,
precautions, and potential complications. See the
warranty card or technical manual for information
concerning warranties. Caution Federal law
(USA) restricts these devices to sale by or on
the order of a physician. 
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DISCLOSURE FOR INSYNC MARQUIS 7277
GENERATOR Indications The InSync Marquis
system is indicated for ventricular
antitachycardia pacing and ventricular
defibrillation for automated treatment of life
threatening ventricular arrhythmias, and for the
reduction of the symptoms of moderate to severe
heart failure (NYHA Functional Class III or IV)
in those patients who remain symptomatic despite
stable, optimal medical therapy, and have a left
ventricular ejection fraction less than or equal
to 35 and a QRS duration greater than or equal
to 130 ms.  ContraindicationsThe InSync
Marquis is contraindicated in         Patients
whose ventricular tachyarrhythmias may have
transient or reversible causes.        
Patients with incessant VT or VF        
Patients who have a unipolar pacemaker Warnings/
Precautions         Changes in patients
disease and/or medications may alter the efficacy
of the devices programmed parameters.        
Patients should avoid sources of magnetic and
electromagnetic radiation, including MRI,
diathermy, and electrosurgical units, to avoid
possible underdetection, inappropriate therapy
delivery, and/or electrical reset of the
device.         Certain programming and device
operations may not provide cardiac
resynchronization.         Do not place
transthoracic defibrillation paddles directly
over the device. See the appropriate technical
manuals for detailed information regarding
instructions for use, indications,
contraindications, warnings and precautions, and
potential adverse events. Caution Federal law
(USA) restricts this device to sale by or on the
order of a physician.
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MEDTRONIC CARELINK? PROGRAMMER SYSTEMThe
Medtronic CareLink programmer system is comprised
of prescription devices indicated for use in the
interrogation and programming of implantable
medical devices. Prior to use, refer to the
Programmer Reference Guide as well as the
appropriate programmer software and implantable
device technical manuals for more information
related to specific implantable device models.
Programming should be attempted only by
appropriately trained personnel after careful
study of the technical manual for the implantable
device and after careful determination of
appropriate parameter values based on the
patient's condition and pacing system used. The
Medtronic CareLink programmer must be used only
for programming implantable devices manufactured
by Medtronic or Vitatron. See the appropriate
technical manuals for detailed information
regarding instructions for use, indications,
contraindications, warnings and precautions, and
potential adverse events. Caution Federal law
(USA) restricts these devices to sale by or on
the order of a physician. DISCLOSURE Indicatio
ns/Contraindications The Medtronic CareLink
Monitor is a prescription device indicated for
use in the transfer of patient data from some
Medtronic implantable cardiac devices based on
physician instructions and as described in the
product manual. This product is not a substitute
for appropriate medical attention in the event of
an emergency and should only be used as directed
by a physician. Medtronic CareLink is currently
available in the continental US, Alaska and
Hawaii