RYTHMIQ™

© 2012 by Boston Scientific Corporation or its affiliates. All rights reserved. CRM-59709-AA

INGENIO™ offers RYTHMIQ, which is

designed to minimize unnecessary RV pacing without

clinically significant pauses

RYTHMIQ™


Minimize unnecessary RV Pacing without clinically significant pauses

Provide valuable diagnostic information with an EGM during RYTHMIQ events

Provide options for patients with varying levels of conduction block

Feature BenefitsRYTHMIQ™


1. Wilkoff, Bruce and The DAVID Trial Investigators. Dual-Chamber Pacing or Ventricular Backup Paciing in Patients with anImplantable Defibrillator: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002; 288: 3115-3123.2. MOST - Lamas, Gervasio, et. All. Ventricular Pacing or Dual-Chamber Pacing for Sinus-Node Dysfunction. N Engl J Med 2002; 346: 1854-62:3. AHA/HRS/ESC guidelines Vol. 48, No. 5, 2006

Studies suggest that unnecessary RV pacing can have deleterious effects1,2

There is also a perception that ALL RV pacing has deleterious effects

AHA/HRS guidelines3 recommend devices have automatic pacing mode selecting algorithms to help reduce the amount of unnecessary RV pacing

Managing RV PacingRYTHMIQ™


Temporary AV Block

AV Conduction Restored

RYTHMIQ™ is designed to minimize unnecessary RV pacing without clinically

significant pauses

Design GoalsRYTHMIQ™


AV Synchrony Restored

RYTHMIQ operates in AAI(R) pacing mode with VVI backup during times of normal conduction, switching to

DDD(R) mode when a conduction block is detected

Loss of AV

Synchrony

OperationRYTHMIQ™


• The device provides AAI(R) at the LRL and/or sensor indicated rate with backup VVI pacing at a rate of 15 bpm slower than the LRL

• When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background

During normal conduction, RYTHMIQ operates like two pacemakers running concurrently – one in AAI(R)

mode and one in VVI mode.

Normal Conduction

OperationRYTHMIQ™


The device monitors for loss of AV synchrony to determine when to switch to DDD(R) mode

Loss of AV Synchrony

• If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode.

• A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.

Loss of AV Synchrony

OperationRYTHMIQ™


#1 #2 #3

INGENIO™ records a RYTHMIQ Episode along with 20 seconds of electrogram data when RYTHMIQ

detects loss of AV synchrony.

This can help the clinician to diagnose patient rhythm conduction disorders and determine appropriate algorithms and pacemaker settings

OperationRYTHMIQ™


If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.

The device uses AV Search+ to periodically check for a return of intrinsic conduction and determine when to mode switch back to AAI(R) with VVI backup.

Normal Conduction Restored


OperationRYTHMIQ™



RYTHMIQ is designed to adapt to a patient’s conduction disorder, by mode switching when AV synchrony is lost or

restored, without clinically significant pauses

OperationRYTHMIQ™

Loss of AV

Synchrony


If RYTHMIQ went directly from AAI(R) into ATR Mode Switch, when the mode switch ends, it goes directly back

into AAI(R) mode

Exception During ATR Mode SwitchRYTHMIQ™


RYTHMIQ is designed to minimize unnecessary pacing without clinically significant pauses

RYTHMIQ operates like two pacemakers running concurrently—one in AAI(R) and one in VVI

RYTHMIQ does not require dropped ventricular beats to switch to DDD(R) pacing

Reference Guide, INGENIO Pacemaker, Page 2-53, 358577-001 EN US 11/10

OperationRYTHMIQ™


Studies have shown that long ventricular pauses can have deleterious effects:

1 May 2006 HRS (Heart Rhythm Society) journal abstract – Inappropriate application of Managed Ventricular Pacing (MV) in a patient with Brugada Syndrome.2 Medtronic CDRM Product Performance Report — Interactions between Cardiac pacing and Ventricular Arrhythmia Initiation3 Gray CJ, Basta MN, Sapp, JL, Parkash R, Gardner MJ. Inappropriate application of “MVP”. Heart Rhythm. 2006, May; 3(5): Supplement P1–89.

The use of MVP may cause unnecessary pauses in pacing therapy. These pauses may be pro-arrhythmic or may be the cause of mild to severe patient symptoms.1

MVP may allow ventricular cycle variations and occasional pauses of up to twice the lower rate2

“This [MVP] pacing mode, while minimizing RV pacing may increase the risk of pause mediated polymorphic VT/VF in patients at risk for bradycardia-induced arrhythmias, particularly in those prone to AV block”3

Why Use RYTHMIQ?RYTHMIQ™


Patients may require different algorithms at various stages of their conduction disease. RYTHMIQ adds another RV pacing algorithm

to Boston Scientific devices, because no one algorithm is appropriate for every patient.

AV Search+ is designed to reduce unnecessary RV pacing by providing backup ventricular pacing for every beat while searching for intrinsic activity

Managing RV Pacing – Two AlgorithmsRYTHMIQ™

BSC also offers AV Search+


Patient’s AV Conduction

StatusBoston

Scientific1 Medtronic2 St. Jude3

Normal RYTHMIQ™MVP®

Nominally ON for all patients

Search AV™

VIP™

Only available algorithm

1st Degree Block RYTHMIQ™

2nd Degree Block AV SEARCH+

3rd Degree Block5

Fixed AV Delay

1) Therapy recommendations made by Indications-Based Programming2) Source: Medtronic Adapta/Versa/Sensia Pacemaker Programming Guide (M929948A001C 2008-01-18)3) Source: St. Jude Medical Unity Platform Reference Guide (60020476A, 07/09)Boston Scientific Indications-Based Programming would recommend paced/sensed AV delays. While not an algorithm, an equivalent setting would be available in competitor devices

With both RYTHMIQ™ & AV Search+, clinicians now have options to appropriately manage RV pacing in patients with varying degrees of conduction block

INGENIO™ pacemakers have two algorithms to help minimize unnecessary RV pacing

Managing RV Pacing – Two AlgorithmsRYTHMIQ™


Minimize unnecessary RV Pacing without clinically significant pauses

Provide valuable diagnostic information with an EGM during RYTHMIQ events

Provide options for patients with varying levels of conduction block

Feature BenefitsRYTHMIQ™


RYTHMIQ™ minimizes unnecessary RV pacing without clinically significant pauses

RYTHMIQ™


Brief SummaryPacing Systems from Boston Scientific IndicationsPacemaker indications include: symptomatic paroxysmal or permanent second- or third-degree AV block; symptomatic bilateral bundle branch block; symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders; bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes. Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity. Pacemakers’ dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are specifically indicated for: conduction disorders that require restoration of AV synchrony, including varying degrees of AV block; VVI intolerance (eg, pacemaker syndrome) in the presence of persistent sinus rhythm or low cardiac output or congestive heart failure secondary to bradycardia.ContraindicationsPacemakers are contraindicated for the following patients under the circumstances listed: patients who have a separate implanted cardioverter-defibrillator (ICD); use of Minute Ventilation in patients with both unipolar atrial and ventricular leads single-chamber atrial pacing in patients with impaired AV nodal conduction; atrial tracking modes for patients with chronic refractory atrial tachyarrhythmias (atrial fibrillation or flutter), which might trigger ventricular pacing; dual-chamber and single-chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias; asynchronous pacing in the presence (or likelihood) of competition between paced and intrinsic rhythms. WarningsRead the product labeling thoroughly before implanting the pulse generator to avoid damage to the system. For single use only. Do not reuse, reprocess or resterilize. Always have external defibrillation protection available during implant and electrophysiologic testing. Do not use this pulse generator with another pulse generator. In response to applicable nonrecoverable or repeat fault conditions, the pulse generator will switch irreversible to Safety Core operation. Do not kink, twist, or braid leads. Do not use atrial tracking modes inn patients with chronic refractory atrial tachyarrhythmias. In devices with the lead safety switch programmed to On, the lead polarity will switch to unipolar in the presence of a lead impedance of ≤ 200 or ≥ 2000 Ω. If programmed to a fixed atrial sensitivity value of 0.15 mV, the pulse generator may be more susceptible to electromagnetic interference. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device. Do not expose a patient to MRI scanning. Do not subject a patient with an implanted pulse generator and/or lead to diathermy.Inappropriate sustained high-rate pacing occurred in the PULSAR™ MAX clinical study in 5 out of 130 patients with MV ON, 4 to 14 days after implant. If sustained high-rate pacing could be of concern, consider programming a reduced Max Sensor Rate or MV to Passive. These programming recommendations are intended to assure that MV calibration is evaluated and, if necessary, recalibrated (4 ON) when the patient and pacing system have stabilized post implant. Continued monitoring of the MV sensor performance should be performed at all follow-up visits until implant stabilization has occurred. PrecautionsFor specific information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization and storage; lead evaluation and connection; implantation; device programming; environmental and medical therapy hazards; hospital and medical environments ; home and occupational environments; follow up testing; explant and disposal; TENS; electrocautery and RF ablation; ionizing radiation; elevated pressures. Advise patients to avoid sources of electric or magnetic interference (EMI). If the pacemaker inhibits or reverts to asynchronous operation at the programmed pacing rate or at the magnet rate while in the presence of the EMI, moving away from the source or turning it off will usually allow the pulse generator to return to its normal mode of operation.Potential Adverse EventsPotential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (pacing/sensing), infection, procedure related, and component failure. In rare cases severe complications or device failures can occur. Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.(Rev. P)

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RYTHMIQ™