INTUA™ Specifications

V273 (IS-1) V272 (LV-1)

Volume (cc) 15.0

Projected Longevity1 (yrs) 8.9

Warranty1 (yrs) 6

Wireless Yes

Remote Patient Management LATITUDE® NXT

Power Supply Lithium-manganese Dioxide

Automatic Threshold RA & RV

Cardiac Rhythm ManagementOne Boston Scientific PlaceNatick, MA 01760-1537 USAwww.bostonscientific.com

Medical Professionals:1.800.CARDIAC (227.3422)Patients and Families:1.866.484.3268

© 2013 Boston Scientific Corporationor its affiliates. All rights reserved.

CRM-169710-AA JUL2013

INTUA™ CRT-P

Treat your patients with the CRT-P that uses Li/MnO2 battery chemistry and has the longest warranty, plus 6 pacing vectors. INTUA is a sophisticated new option projected to last longer than any other CRT-P1,2,3,4. Because the most advanced therapy is the one that, once implanted, allows your patients to get back to what’s important in life.

CRT-P Systems from Boston Scientific - INTUA™ and INVIVE™

Indications: The INVIVE and INTUA cardiac resynchronization therapy pacemakers (CRT-Ps) are indicated for patients who have moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF ≤ 35%) and QRS duration ≥ 120 ms and remain symptomatic despite stable, optimal pharmacologic therapy for heart failure. Atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with increases in physical activity.

Contraindications: These devices are contraindicated in patients who have a separate implanted cardioverter-defibrillator (ICD).

Single-chamber atrial pacing is contraindicated in patients with impaired AV nodal conduction. Atrial tracking modes are contraindicated for patients with chronic refractory atrial tachyarrhythmias (atrial fibrillation or flutter), which might trigger ventricular pacing. Asynchronous pacing is contraindicated 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 non-recoverable 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 in patients with chronic refractory atrial tachyarrhythmias. Do not use atrial only modes in patients with heart failure. 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. Left ventricular (LV) lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition.

Precautions: For specific information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization and storage; implantation; device programming; environmental and medical therapy hazards; hospital and medical environments ; home and occupational environments; follow up testing; explant and disposal; and supplemental precautionary information. Advise patients to avoid sources of electric or magnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.

Potential Adverse Events: Potential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (pacing/sensing), infection, lead tip deformation and/or breakage, 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. B)

LATITUDE® NXT Patient Management System from Boston Scientific CRM

Intended Use: The LATITUDE NXT Patient Management system is intended for use to remotely communicate with a compatible pulse generator from Boston Scientific CRM and transfer data to a central database. The LATITUDE NXT system provides patient data that can be used as part of the clinical evaluation of the patient.Contraindications: The LATITUDE NXT Patient Management system is contraindicated for use with any implanted device other than a compatible Boston Scientific implanted device. Not all Boston Scientific im-planted devices are compatible with the LATITUDE NXT system. For contraindications for use related to the implanted device, refer to the System Guide for the Boston Scientific implanted device being interrogated.Precautions: Alerts may appear on the LATITUDE NXT website on a daily basis. Primary notification of alert conditions is through the View Patient List page on the LATITUDE NXT website. The clinician needs to log onto the LATITUDE NXT website in order to receive alerts. Although secondary notification through email and SMS text messages is available, these reminders are dependent on external systems and may be delayed or not occur. The secondary notification feature does not eliminate or reduce the need to check the website. Implanted device data and alerts are typically available for review on the LATITUDE NXT website within 15 minutes of a successful interrogation. However, data uploads may take significantly longer (up to 14 days). If the Communicator is unable to interrogate the implanted device or if the Communicator is unable to contact the LATITUDE NXT server to upload data, up to two weeks may elapse before the LATITUDE NXT server detects these conditions and informs the clinic user that monitoring is not occurring. If both of these conditions occur at the same time, this notification could take up to 28 days. Implanted device data and alert notification may be delayed or not occur at all under various conditions, which include but are not limited to the following: System limitations; the Communicator is unplugged; the Communicator is not able to connect to the LATITUDE NXT server through the configured phone system; the implanted device and the Communicator cannot establish and complete a telemetry session; the Communicator is damaged or malfunctions; the patient is not compliant with prescribed use or is not using the LATITUDE NXT system as described in the patient manual; if subscribed to the LATITUDE Cellular Data Plan, missing two or more payments discontinues the subscription; the clinic user can identify any patients that are not being monitored as described above by using the Not Monitored filter on the View Patient List.

Adverse Effects: None known.

System Limitations: The LATITUDE NXT system does not provide continuous real-time monitoring. As a remote monitoring system, the LATITUDE NXT system provides periodic patient monitoring based on clinician configured settings. There are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of implanted device, sensor, and patient information as intended by the clinician. These factors include: implanted device clock; patient environment; cellular data service; telephone system; communicator memory capacity; clinic environment; schedule/configuration changes; or data processing.

Refer to the product labeling for specific instructions for use. Rx only.(Rev. A)

INTUA™

Intervention made intelligent

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Monitor Respiration, Weight, Blood Pressure & Diagnostics

• INTUA™ features HF PERSPECTIV™, which provides diagnostics allowing clinicians to more confidently make informed treatment decisions in an effort to treat heart failure

Maximum Rate

Median Rate

Minimum Rate

• Most specific measure of activity level• Should be significantly higher than the minimum (up to 3-4 times that of resting) and vary day to day

• Change in Med or Min RR may reflect change in heart failure status• NOTE: Minimum ≥ 20 breaths per minute is indicator of rapid, shallow breathing

• Corresponds most closely to resting respiration rate• Normal median respiratory rate is approximately 14-18 breaths per minute• Change in Med or Min RR may reflect change in heart failure status

Respiratory RateMax: 35 rpmMedian: 13 rpmMin: 10 rpm

Connectivity

Remote Patient Management - LATITUDE® NXT

• INTUA™ can be followed remotely using Boston Scientific’s LATITUDE NXT system

• LATITUDE NXT features a communicator including:

– Integrated cellular capability

– Single button design including a visual confirmation of successful data transmission

Sources

5. When using a bipolar lead

6. Champagne, J, Healey JS, Krahn AD, et al. The effect of electronic repositioning on left ventricular pacing and phrenic nerve stimulation. N=228, Europace. 2011

Reposition Leads Electronically

• INTUA™ features Electronic Repositioning™, which is designed to avoid LV lead revisions

• INTUA has 6 pacing and 5 sensing vectors5 — more than competitive CRT-Ps

Electronic Repositioning Vectors

LV Tip to LV Ring LV Ring to LV Tip LV Tip to RV Ring

LV Ring to RV Ring LV Ring to CanLV Tip to Can

• INTUA™ uses the same Li/MnO2 battery chemistry used in our ICDs and CRT-Ds and features an industry-leading projected longevity of 8.9 years

• INTUA™ is backed by an industry-leading 6 year warranty1,2,3,4

Projected Longevity

• >95% of patients were free of phrenic nerve stimulation at implant with Boston Scientific’s bipolar CRT system6

• Respiratory Rate Trend displays a graph of the patient’s daily minimum, maximum, and median respiratory rate values

• HF PERSPECTIV also includes: Activity Level, Heart Rate Trend, Atrial Arrhythmia Burden, Heart Rate Variability (HRV) Footprint and SDANN. These diagnostics can be followed remotely through LATITUDE® NXT

• LATITUDE Heart Failure Management system with weight scale and blood pressure monitor is now included*

• Following a patient’s respiratory rate or weight & blood pressure may qualify for monthly reimbursement under the ICM code

*When ordered within 1 year of implant.

Wireless during Implant & Follow-up:

• INTUA™ and LATITUDE® NXT can provide daily alerts to clinicians including atrial arrhythmia burden and percentage of CRT pacing

• Device can be programmed and diagnostics checked while the physician is suturing

• Wand not required for device checks

1. INTUA PHYSICIAN’S TECHNICAL MANUAL (358572-001 EN US 2012-09) 70ppm, DDDR, 100% Bi-V pacing, 15% atrial pacing, RA/RV=2.0V, LV=3.0V, 500Ω, 0.4ms pulse width, RV & RA Automatic Threshold “ON”, sensors “ON”, Onset EGM “ON”, Warranty information: http://www.bostonscientific.com/templatedata/imports/HTML/PPR/ppr/warranty.shtml

2. Medtronic Consulta CRT-P Clinician Manual (M928142A001, 10/10), DDD, 2.5V RA/RV amplitudes, 3.0V LV amplitude, 0.4ms pulse width, 500Ω, 15% A paced, 100% BiV paced

3. St. Jude Medical Bradycardia and Tachycardia Devices Help Manual (60031655/A, April 2012), St. Jude Medical Anthem RF Specification Sheet, Item No. G0207, 70bpm, 100% DDD-BiV pacing, 2.5V RA/RV/LV, 0.5ms pulse width, 500Ω, Cap Confirm “OFF”, 5 year warranty

4. Biotronik Evia HF/HF-T Technical Manual M4142-A 10/12, Implantable Pulse Generator Warranty M4142-A 10/12 , 60bpm, 3.0V, 0.4ms pulse width, 500Ω (only setting published in manual), 5 year warranty

Projected longevityYears

BostonScientificINTUA™,1

Medtronic Consulta®2

St. Jude Anthem® RF3

Biotronik Evia HF-T4

8.9 8.4

6.7 6.4

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