Continuously records and deletes the patient’s

Patient-activation function ECG and auto activation (daily automatic) transmissions for pre-specified criteria.

Capture of arrhythmic events without relying on patient compliance or perception of symptoms

RETROSPECTIVE (LOOP) MEMORY

Patients with infrequent short duration transient symptoms,

recurring over months

Subcutaneous Electrocardiographic (ECG) Monitoring Device

Reveal® Plus ICM Reveal® DX Reveal® XT ICM

2000 2007 2009:

Sensing Onda R Soglia fissa Soglia dinamica

Risposta alle interferenze

Soglia dinamica

Risposta alle interferenze

Trigger episodi Asistolia, Bradicardia,

Tachicardia

Asistolia, Bradicardia

VT/FVT

Asistolia, Bradicardia

VT/FVT, AT/AF

Diagnostica estesa no no

AF detection

Burden AT/AF, HRV, Attività del paziente, FC Diurna/Notturna,

Cardiac Compass

Sistema di mappaggio Cardboard Vector Check Vector Check

Interfaccia utente No Medtronic standard Medtronic ICD style Medtronic ICD style

Durata 14 mesi 3 anni 3 anni

Memorizzazione Eventi 42 min. 49.5 min. 49.5 min.

Patient Assistant Singola funzione:

Sintomo

Doppia funzione:

Sintomo e feedback

3 funzioni: Sintomo, Feedback e query

Risonanza magnetica no Si Si

Remote Monitoring no Medtronic CareLink® Network Medtronic CareLink® Network

6

7

CARATTERISTICHE VALORE

Dimensioni (altezza x larghezza x spessore) 56,3 mm x 18,5 mm x 8 mm

Volume 6,5 cc

Peso 12 g

Longevità stimata 3 anni

56,3 mm 8 mm

18,5

mm

Gli elettrodi sottocutanei sul dispositivo semplificano la procedura di impianto ed eliminano la necessità di utilizzare elettrodi transvenosi

Posizionamento degli elettrodi appositamente studiato per avere un riconoscimento migliore degli episodi grazie ad un buon contatto tra sensore e tessuto

Elettrodo frontale Elettrodo retro

Uses the same interval, interval average algorithm that ICDs use to bin or classify intervals as Tachy, Brady or Asystole.

• SJM Confirm™ Implantable Cardiac

Monitor (ICM)

• Patient Activator

• Merlin™ Patient Care System (PCS)

• Transtelephonic service provider

A weekly trend based on the percentage of time the patient spent in atrial

fibrillation based on the AF duration programmed in parameters.

Will also be displayed on the FastPath™

Provides the mean ventricular rate during AF and a histogram of recorded AF

episode durations

Provides a link to the AF Diagnostics screen.

Parameter Reveal LINQ ICM

Longevity *3 years

Long 7.2 mm

Wide 4.0 mm thick

WEIGH 2.5 g

Electrode Spacing (inside-to-inside) 38 mm

Volume 1.2 cc

Mass 2.5 g

Episode Storage 59 min

Patient Symptom Mark Patient Assistant

Cardiac Compass® Same

MRI Compatibility MR Conditional

Clinician Notification Nightly Transmission / CareAlert

Notifications

Bi-Directional Telemetry B

Detection Algorithms Full View + P-SENSE detection

CareLink® Network Yes

Wireless Telemetry 1-Way, Transmit Only

Insertable

Automatic transmission

AF detection

P-sense

Cardiac Compass®

Electrodes on the ends of the device record

ECG signals

An embedded accelerometer measures

patient activity

Uses wireless telemetry for remote

monitoring of patients (including nightly

automated transmissions)

2014

LINQ Device

Tool di inserzione Tool di Incisione

+

87% PIU’ PICCOLO DEL Reveal® XT

Benefici della miniaturizzazione

12

Simplify implantation

procedure

Increase patient acceptance

Enhance the device’s AF detection capabilities.

13

TECHNOLOGICAL ADVANCES

Reveal LINQ e Trasmissione Wireless

Carelink Network

CareAlerts

Segnalazione con un Event Report, contenente

•Dati Device (i.e. Batteria)

•30 s di ECG di un Episodio, secondo le priorità impostate

•Numero Episodi

No Segnalazione

Disponibili: i Dati Device, 10 sec di ECG Corrente ed i contatori

Disponibili 30 sec di ECG trasmesso nella lista episodi

Ogni 31 gg, un Summary Report verrà comunque generato con i Dati Device, i 10 sec di ECG Corrente e contatori dall’ultima trasmissione, Trend e Cardiac Compass

:

New Frontiers in Cardiac Monitoring

Patient

Assistant

Cellular

• Sincope

• Palpitazioni

• Convulsioni

• Tachicardia ventricolare

• AF sospetta

• Ablazione AF

• Gestione AF

• Ictus criptogenetico

• Altro

Selezionare la Ragione del Monitoraggio:

La scelta del motivo del monitoraggio permette una preselezione della programmazione più specifica

17

18

• Its smaller size makes it much more suitable for children and infants

• It is technically easy to implant • Automatic transmission to

CareLink • Ideal for patients asymptomatic

who require constant monitoring

11-MONTH-OLD boy with tuberous sclerosis with frequent ventricular arrhythmias secondary to cardiac Rhabdomyomas.

Cardiology in the Young (2015), 25, 1221–1223

Conclusions: The miniaturized Reveal LINQ ICM supports arrhythmia detection and monitoring, achieving adequate sensing performance without safety issues

Heart Rhythm, Vol 12, No 6, June 2015 1116

Incidence of AF episodes

Duration of AF Cumulative time

spent in AF

(AF burden)

Ventricular rate during AF

Average Day Night Heart Rate Heart Rate Variability

Patient Activity

Can store up to 14 AF episodes with electrocardiogram (ECG) data after which the earliest episode gets overwritten by

newer episodes

20

mfalse positive Duration 55% Number of 46%

Purerfellner H, Heart Rhythm 2014; 11: 1575–1583.

Symptom- Rhythm Correlation

-Management of transient loss of consciousness (T-LOC)

-Evaluation of syncope

Management of Palpitations

Silent Atrial Fibrillation

22

WITH 3 YEAR BATTERY LIFE OFFERS THE BEST OPPORTUNITY FOR

DIAGNOSIS

In patients with frequent recurrences of unexplained syncope, the 2009 European Society of Cardiology (ESC) guidelines now advocate the “early” use of ILRs.

• Prospective, Multicenter, observational study • 570 pts with recurrent unexplained presyncope

or syncope • ILR provided a diagnosis in 78% of the patients

Brignole et al. Europace (2009) 11, 671–687

Task Force

Suggested ECG monitoring techniques

depending on symptom frequency

Diagnosing bradyarrhythmic syncope after the

initial evaluation: most useful tests

Non-invasive evaluation of patients with

suspected or known ventricular arrhythmias

Time ICM (%) Control (%) Hazard Ratio

P

6 months 8.9 1.4 6.4 0.0006

12 months 12.4 2.0 7.3 0.0001

3 years 30.0 3.0 8.8 0.0001 29

N Engl J Med 2014;370:2478-86

Dramatic increase in the detection rate (30% versus 3%)

of atrial fibrillation at 36 months.

Implantable REVEAL XT Device Conventional Monitoring

441 pts

End Point Primario

End Point Secondario

Heart Failure

Bradycardia

Atrial

Fibrillation

Tachycardia

Manage

Treat Predict

Diagnose

• ILRs is safe and cost-­effective and has a high diagnostic yield

• Maximizes clinical benefits while simultaneously lowering costs or improving economic

2015

Heart Rhythm, Vol 12, No 7, July 2015