1. RYTHMIQ™
INGENIO™ offers RYTHMIQ, which is designed to minimize unnecessary RV pacing without clinically significant pauses

2. RYTHMIQ™ Feature Benefits
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

3. RYTHMIQ™
Managing RV Pacing
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
Were you around when David trial came out? What happened to the industry? (We started pacing everyone)
So the pendulum swung all the way from one side to the other. We went from 100% RV pacing to trying to get to 0%. But now, we’re realizing that some RV pacing might be okay. It’s not “ALL RV pacing”, it’s UNNECESSARY RV Pacing”.
INTRINSIC RV demonstrated that if RV pacing got to 0, there was a higher % of death than with some patient.
What % of RV pacing do you think is appropriate?
Which patient population is at risk when you try to get to 0% RV pacing? (complete heart block, first and second degree heart block, paused induced VT or VF) If you aggressively do not pace them, you can promote deadly arrhythmias.
1. Wilkoff, Bruce and The DAVID Trial Investigators. Dual-Chamber Pacing or Ventricular Backup Paciing in Patients with an
Implantable Defibrillator: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002; 288:
2. MOST - Lamas, Gervasio, et. All. Ventricular Pacing or Dual-Chamber Pacing for Sinus-Node Dysfunction. N Engl J Med 2002; 346: :
3. AHA/HRS/ESC guidelines Vol. 48, No. 5, 2006

4. RYTHMIQ™
Design Goals
RYTHMIQ™ is designed to minimize unnecessary RV pacing without clinically significant pauses
Temporary AV Block
RYTHMIQ™ is designed to eliminate unnecessary ventricular pacing for patients who appear to have normal AV conduction, and to prevent clinically significant pauses as defined by the 2008 ACC/AHA/HRS guidelines” and short cycle of dual chamber pacing (Ap-Vp). Also, the ACC/AHA/NASPE 2002 Guidelines recommended the use of an algorithm to avoid unnecessary right ventricular apical pacing, in patients with normal native QRS duration and no intra-ventricular conduction abnormalities. This new feature serves patients with normal AV conduction and adapts to
Patient that develop AV de-synchrony (AV block)
Patient that develop spontaneous atrial fibrillation (AF)
AV Conduction Restored

5. RYTHMIQ™
Operation
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
AV Synchrony Restored
RYTHMIQ and conduction block
When intact conduction is present RYTHMIQ™ is pacing in AAI(R) with VVI backup to eliminate unnecessary right ventricular pacing. It operates as 2 separate pacemakers that immediately triggers a EGM and switch to DDD(R) pacing when a conduction block is detected. To switch back to AAI(R) pacing AV Search+ is used to periodically check for a return of intrinsic conduction.

6. RYTHMIQ™
Operation
During normal conduction, RYTHMIQ operates like two pacemakers running concurrently – one in AAI(R) mode and one in VVI mode.
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
RYTHMIQ and conduction block
When intact conduction is present RYTHMIQ™ is pacing in AAI(R) with VVI backup to eliminate unnecessary right ventricular pacing. It operates as 2 separate pacemakers that immediately triggers a EGM and switch to DDD(R) pacing when a conduction block is detected. To switch back to AAI(R) pacing AV Search+ is used to periodically check for a return of intrinsic conduction.
Normal Conduction

7. RYTHMIQ™
Operation
The device monitors for loss of AV synchrony to determine when to switch to DDD(R) mode
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
RYTHMIQ and conduction block
When intact conduction is present RYTHMIQ™ is pacing in AAI(R) with VVI backup to eliminate unnecessary right ventricular pacing. It operates as 2 separate pacemakers that immediately triggers a EGM and switch to DDD(R) pacing when a conduction block is detected. To switch back to AAI(R) pacing AV Search+ is used to periodically check for a return of intrinsic conduction.
Loss of AV Synchrony

8. RYTHMIQ™
Operation
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
“When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data. The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
# # #3

9. RYTHMIQ™
Operation
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.
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.
AV Synchrony Restored
RYTHMIQ and conduction block
When intact conduction is present RYTHMIQ™ is pacing in AAI(R) with VVI backup to eliminate unnecessary right ventricular pacing. It operates as 2 separate pacemakers that immediately triggers a EGM and switch to DDD(R) pacing when a conduction block is detected. To switch back to AAI(R) pacing AV Search+ is used to periodically check for a return of intrinsic conduction.
Normal Conduction Restored

10. RYTHMIQ™
Operation
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
Loss of AV Synchrony
AV Synchrony Restored
RYTHMIQ and conduction block
When intact conduction is present RYTHMIQ™ is pacing in AAI(R) with VVI backup to eliminate unnecessary right ventricular pacing. It operates as 2 separate pacemakers that immediately triggers a EGM and switch to DDD(R) pacing when a conduction block is detected. To switch back to AAI(R) pacing AV Search+ is used to periodically check for a return of intrinsic conduction.

11. RYTHMIQ™
Exception During ATR Mode Switch
If RYTHMIQ went directly from AAI(R) into ATR Mode Switch, when the mode switch ends, it goes directly back into AAI(R) mode
RYTHMIQ and atrial arrhythmia
This feature is designed for patients with intact conduction to pace AAI(R) with VVI backup to eliminate unnecessary right ventricular pacing. It operates a 2 separate pacemakers that immediately mode switches when an atrial arrhythmia is detected (ATR mode). If the mode switch ends RYTHMIQ™ will return to normal AAI(R) mode but it has also the flexibility to switch directly to DDD(R) or visa versa.

12. RYTHMIQ™
Operation
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, EN US 11/10

13. RYTHMIQ™
Why Use RYTHMIQ?
Studies have shown that long ventricular pauses can have deleterious effects:
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
May 2006 HRS (Heart Rhythm Society) journal abstract – Inappropriate application of Managed Ventricular Pacing (MV) in a patient with Brugada Syndrome.
Medtronic CDRM Product Performance Report — Interactions between Cardiac pacing and Ventricular Arrhythmia Initiation
Gray CJ, Basta MN, Sapp, JL, Parkash R, Gardner MJ. Inappropriate application of “MVP”. Heart Rhythm. 2006, May; 3(5): Supplement P1–89.

14. BSC also offers AV Search+
RYTHMIQ™
Managing RV Pacing – Two Algorithms
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.
BSC also offers AV Search+
AV Search+ is designed to reduce unnecessary RV pacing by providing backup ventricular pacing for every beat while searching for intrinsic activity

15. Patient’s AV Conduction Status
RYTHMIQ™
Managing RV Pacing – Two Algorithms
INGENIO™ pacemakers have two algorithms to help minimize unnecessary RV pacing
Patient’s AV Conduction Status
Boston Scientific1
Medtronic2
St. Jude3
Normal
RYTHMIQ™
MVP®
Nominally ON for all patients
Search AV™
VIP™
Only available algorithm
1st Degree Block
2nd Degree Block
AV SEARCH+
3rd Degree Block5
Fixed AV Delay
With both RYTHMIQ™ & AV Search+, clinicians now have options to appropriately manage RV pacing in patients with varying degrees of conduction block
Therapy recommendations made by Indications-Based Programming
2) Source: Medtronic Adapta/Versa/Sensia Pacemaker Programming Guide (M929948A001C )
3) Source: St. Jude Medical Unity Platform Reference Guide ( A, 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

16. RYTHMIQ™ Feature Benefits
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

17. RYTHMIQ™
RYTHMIQ™ minimizes unnecessary RV pacing without clinically significant pauses
A self balanced system that lets the heart take the lead;
- RightRate™ drives atrial pacing rate and RYTHMIQ™ will respond when AV conduction blocks occur
- The ventricular rate input in trending updates the Auto Response Factor used in the RightRate™ feature.
This unique combination of INGENIO’s RightRate™ and RYTHMIQ™ features make it the only pacemaker to provide symptomatic sick sinus patients with the appropriate hearts rates they need while minimizing unnecessary RV pacing.

18. Brief Summary
Pacing Systems from Boston Scientific Indications Pacemaker 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. Contraindications Pacemakers 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. Warnings Read 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. Precautions For 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 Events Potential 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)