11MM
Patient comfort and
optimal performance
YOU ASKED, WE LISTENED.
Thin, powerful, long lasting, in one optimal combination
THIN – 11mm for exceptional comfort
• Patient comfort without sacrificing performance
Sorin listened closely to what physicians wanted while designing PARADYM™ RF.
The result is a remote monitor-enabled ICD family that combines 94% overall arrhythmia
discrimination specificity with <1% pacing (DR model) in a thin, powerful, long-lasting can.
PARADYM RF ICD
TACHYARRHYTHMIA MANAGEMENT
POWERFUL – 42J, 37J delivered
• High energy, safely delivered
LONG LASTING – Longevity by design
• Optimal power combination of wet tantalum capacitor and QHR®* battery
• Remote monitor-initiated wake-up for daily checks designed to preserve longevity
• SafeR™ increases device longevity compared to DDD mode1
Typical Longevity
Proven – Optimal outcomes made simple
• 99% for SVT3
• Fewest inappropriate shocks reported2
Liam is 70 and received his first ICD five years ago after being admitted
to the hospital with sustained VT. His first ICD caused him anxiety
as he received several unnecessary shocks caused by his devices
shocking for fast VT. He also received several inappropriate shocks
during exercise.
that PARADYM RF™ ICD is more sophisticated and would
not treat him unless it was absolutely necessary. Moreover,
8.9Y*
11mm
11mm
Power
42J stored
37J delivered
42J stored
37J delivered
Discrimination
V+/Acceleration
PARAD+™
RV Pacing Algorithm
N/A
SafeR™
ATP for fast VT in the VF zone
✓
✓
acing in VVI mode 1%, 500 Ohm, 3.5 V, 0.35 ms, 60 min-1, one 42 J shock per quarter, sensors OFF, remote monitoring: daily check, 4 follow-ups and 5 full
P
alert reports per year
* Pacing in DDD mode, 15% in atrium, 1% in ventricle, 500 Ohm, 3.5 V, 0.35 ms, 60 min-1, one 42 J shock per quarter, sensors OFF, remote monitoring:
daily check, 4 follow-ups and 5 full alert reports per year
• < 1% V pacing4
depleted device due to his anxiety. His doctor reassured him
9.3Y
+
SafeR
Liam was unsure about having a new ICD to replace his
PARADYM RF DR
+
Thinness
PARAD+
94% overall discrimination specificity 2
PARADYM RF VR
LIAM
fast vt
References
1
Benkemoun H, Lagrange P, Himmrich F, Aime E, Guenon C, Pioger G. The SAFER Pacing Mode Significantly Increases Dual Chamber Pacemaker Longevity as
Compared to Standard DDD pacing Modes. Europace 2010; 12, Sup. 1:56P_62.
2
Anselme F, Mletzko R, Bowes R, et al. Prevention of inappropriate shocks in ICD recipients: a review of 10,000 tachycardia episodes. PACE 2007; 30:S128-S133.
Study made using dual-chamber ICDs with standard dual-chamber arrhythmia classification algorithms.
3
Hintringer F, Deibl M, Berger T, Pachinger O, Roithinger FX. Comparison of the Specificity of Implantable Dual Chamber Defibrillator Detection Algorithms. PACE
2004; 27:976-82.
4
Davy, JM, Gras D, Thia A, et al. Determining the Optimal Pacing Mode to Prevent Ventricular Pacing: SAFER study results. Heart Rhythm 2006; 3, supp 5,
P2-94:S169.
5
Van Rees, Borleffs JW, De Bie MK, et al. Inappropriate Implantable Cardioverter-Defibrillator Shocks: Incidence, Predictors, and Impact on Mortality. J Am Coll
Cardiol 2011; 57:556-562.
6
Daubert JP, Zareba W, Cannom DS, et al. Inappropriate Implantable Cardioverter-Defibrillator Shocks in MADIT II Frequency, Mechanisms, Predictors, and Survival
Impact. J Am Coll Cardiol 2008; 51:1357-1365.
7
Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic Importance of Defibrillator Shocks in Patients with Heart Failure. NEJM 2008; 359:1009-17.
8
Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse Effect of Ventricular Pacing on Heart Failure and Atrial Fibrillation Among Patients With Normal Baseline
QRS Duration in a Clinical Trial of Pacemaker Therapy for Sinus Node Dysfunction. Circulation 2003; 107:2932-37.
9
Wilkoff BL, Cook JR, Epstein AE, et al. Dual-Chamber Pacing or Ventricular Backup Pacing in Patients With an Implantable Defibrillator: The Dual Chamber and
VVI Implantable Defibrillator (DAVID) Trial. JAMA 2002;288: 3115-23.
WARNINGS: Refer to User’s Manual furnished with the device for intended uses and relevant warnings, precautions, side effects and contraindications.
Information given in this document may be modified without prior notice.
his new device will last much longer than his previous
model, and his home monitor will keep the hospital
informed of any potential issues.
*QHR is a Greatbatch trademark.
GLOBAL MARKETING
Manufactured in Italy by
Sorin CRM sas
4, avenue Réaumur
92140 Clamart
France
www.sorin.com
Sorin CRM S.r.l.
Via Crescentino s.n.
13040 Saluggia (VC)
Italy
©2011 Sorin CRM SAS - Printed in ITALY - APRIL 2011 - ref: RE06200019 - EN
Individualized therapy.
Monitored performance.
IMAGINE THAT.
ENABLED FOR SmartView™
REMOTE MONITORINg
FEWEST REPORTED
INAPPROPRIATE SHOCKS2
PARAD+
Simple home-to-clinic solution
Too many patients receive inappropriate shocks
• Easy to use for patients and physicians
• 11% to 17% of ICD patients receive at least one inappropriate shock
inappropriate shocks
Burden-free
operation for
physicians
hospitalizations than the DDD group
(59% pacing)9
5
Protect patients with PARAD+
Safeguard patients with SafeR
™
• PARAD+ is the only discriminator to include both long-cycle search and chamber of origin
for 99% SVT specificity
Parad+ analyzes arrhythmias like an ep
PARAD+ automatically
completes the LIKE
stepsAN
an EP
EP would perform to diagnose an arrhythmia
PARAD+
ANALYZES ARRHYTMIAS
UNSTABLE R-R
DISCRIMINATOR
UNSTABLE R-R
STABLE WITH NO
LONG CYCLE
STABLE R-R
NO PR ASSOCIATION
LONGEVITY
High speed data transfer and
monitor-initiated connection designed
to preserve device longevity
STABLE R-R
PR ASSOCIATION
Helpdesk support puts the patient’s
mind at ease and removes the burden
from healthcare providers
STABLE WITH
LONG CYCLE
PR ASSOCIATION
DECISION
DIAGNOSIS
UNSTABLE
AF
NO LONG CYCLE
VT
LONG CYCLE
AF
N:1
AFI
PHYSICIAN ALERTS
PATIENT SETUP
WEB APPLICATION
Easy access to executive
summaries or full reports
Prompt alerts help you make
clinical decisions
ACCELERATION
STABLE R-R
1:1 PR ASSOCIATED
SUDDEN
ACCELERATION
AVB
III
3 BLOCKED
ATRIAL EVENTS /
12 CYCLES
AVB
II
6 LONG
PR INTERVALS
AVB
I
• The first pacing mode to manage all types
• Promotes 99.9% intrinsic conduction4
ARRHYTHMIA
2 CONSECUTIVE
BLOCKED
ATRIAL EVENTS
of AV block
3
Increases efficiency,
reduces workload
approaches to automatically
adapt to any AV block
• VVI patients (3.5% pacing) had fewer
• 76% of inappropriate shocks are due to the misdiagnosis of
supraventricular tachycardia (SVT)
SafeR
Unnecessary ventricular pacing increases
the risk of atrial fibrillation and heart
failure hospitalization8
SafeR™ uses three
5,6,7
• 40%5,6,7 of patients who receive an inappropriate shock will receive recurrent
Plug & play simplicity
for patients
MANAGE ALL TYPES OF
AV BLOCK
A CHAMBER
V CHAMBER
NO
ST
ACC - A
AT
ACC - V
VT
1:1
Clinically proven
• “Using the PARAD+ discrimination algorithm, the absolute patient risk of experiencing an
inappropriate shock was 5%, the lowest recorded thus far2”
Specific functioning during
rest and exercise
• Rapid switch to DDD for patients whose AV
conduction does not adapt during exercise
Specific Functioning During Rest AND Exercise
AAI
DDD
AAI
switch to DDD
Exercise rate = max
(100 bpm; basic rate + 30 bpm)
Exercise rate - 10 bpm