13. DEVICE DESCRIPTION
13. DEVICE DESCRIPTION
The INTENSIA DR system includes the model 154 ICD device and programming system.
The programming system includes the Sorin dedicated programmer with the SMARTVIEW
programming software connected to a CPR3 programming head. The programming system
is configured and furnished by Sorin.
The INTENSIA DR 154 can serve as a defibrillation electrode (active housing) with a total
surface area of 76 cm².
The INTENSIA DR 154 is designed to recognize and treat slow or fast VT and VF by
continuously monitoring atrial and ventricular activity to identify persistent ventricular
arrhythmias and to deliver appropriate therapies. INTENSIA DR 154 features the
PARAD/PARAD+ algorithm, which is specifically designed to differentiate ventricular
tachycardias from fast rhythms of supraventricular origin. PARAD/PARAD+ continuously
monitors R-R interval stability, searches for long cycles, assesses the degree of P-R
association, evaluates sudden onset and determines the chamber of arrhythmia
acceleration.
In addition to the advanced detection scheme, INTENSIA DR 154 offers programmable dual
or single-chamber pacing therapy (DDD, DDI, VVI or SafeR (AAI <> DDD) modes) with or
without rate-responsive capabilities (DDDR, DDIR, VVIR, DDD/DDIR and SafeR-R (AAIR <>
DDDR) modes) using an acceleration sensor. An automatic AV delay algorithm as well as a
mode switching function are available.
INTENSIA DR 154 offers tiered therapy. Therapies can be programmed independently in
each zone:
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in the Slow VT and VT zones: two ATP programs, up to two shocks with programmable
energy and up to four shocks with maximum energy can be programmed;
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in the VF zone: one ATP program, up to two shocks with programmable energy and up
to four shocks with maximum energy can be programmed.
When the rhythm changes from one zone to another, the device delivers the therapy
programmed in this zone, starting with the same or more aggressive program for the area.
The ATP program in the VF zone will only be applied if the VT coupling interval is longer
than the programmed fast VT cycle length.
The INTENSIA DR 154 offers biphasic shocks with a maximum stored energy of 42 J. The
shock configuration (electrodes used to apply the shock) can be chosen by programming
one of the following combinations: can and one coil, can and two coils, two coils only.
Other features are as follows:
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Automatic ventricular sensitivity control
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Non-committed shocks
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Electrophysiological studies (EPS) with real-time markers or electrograms:
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Programmer-controlled VT induction sequences,
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Programmer-controlled VF inductions (30 Hz rapid pacing or shock on T),
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Programmable electrogram vectors (EGM A, EGM V, RVcoil-CAN, SVC-CAN, RVcoil-
SVC),
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Real-time annotations displayed with the markers and indicating the majority rhythm,
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Manual ATP sequences,
─
Manual shocks.
SORIN – INTENSIA DR 154 – U152A
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Summary of Contents for Intensia DR 154
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