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Protecta™ Portfolio Backgrounder

The Medtronic Protecta™ Portfolio

Overview
The Medtronic Protecta™ portfolio of implantable cardioverter-defibrillators (ICDs) and cardiac
resynchronization therapy-defibrillators (CRT-Ds) with SmartShock™ Technology offers
exclusive features to reduce inappropriate shocks. Findings from the Virtual ICD study, based
on a statistical model, predict that 98 percent of studied patients with SmartShock Technology
will be free of inappropriate shocks one year after implant and 92 percent will be free of
inappropriate shock five years after implant.1

Physician and Patient Benefits

Leveraging Medtronic’s industry-leading cardiac rhythm technology and research, the Protecta
portfolio addresses one of physicians’ and patients’ top priorities – reducing inappropriate
shocks. The implantable devices also provide patients with lifesaving technology they can rely
on to live an active life without the worry of experiencing an inappropriate shock.

Protecta Portfolio Exclusives

The first to feature SmartShock™ Technology, the Protecta portfolio includes six Medtronic-
exclusive algorithms that distinguish between life threatening and non-life threatening
arrhythmias and electrical noise within the device system in order to reduce inappropriate
shocks. The following features are automatically on when the device is implanted, thereby
requiring no further programming:

 Three solutions (Wavelet + PR Logic, SVT discrimination in the VF zone, and Confirmation +) in Protecta devices are designed to
discriminate between different non-lethal and lethal arrhythmias to provide lifesaving shock therapy only when necessary.
 T-wave Discrimination and Lead Noise Discrimination features are designed to distinguish between deadly arrhythmias and
oversensing to withhold shock therapy when appropriate.
 Lead Integrity Alert, first released in 2008, provides advanced warning of potential lead fractures so the patient can seek medical
attention, and reduces the risk of receiving an inappropriate shock.

Additional Protecta Features

 OptiVol® Fluid Status Monitoring, a Medtronic-exclusive feature included in all Protecta XT devices that measures changes in fluid build-
up in heart failure patients to identify patients at risk of worsening heart failure.2, 3
 ATP During Charging™, available since 2005, automatically uses pacing pulses to painlessly stop fast, dangerous heartbeats, while
simultaneously preparing to deliver a shock, if needed, to terminate a potentially fatal rhythm. Approximately 75 percent of arrhythmias can
be terminated with painless anti-tachycardia pacing (ATP) technologies and others receive life-saving shock therapy.4 ATP is available in all
Protecta XT ICDs and CRT-Ds.
  Automaticity with Complete Capture Management™ provides doctors with the ability to capture what is happening in the three
chambers of the heart, and then adjust the device’s programming to better fit the body’s physiologic needs. Complete automaticity also
provides physicians flexibility during in-office checks and may enhance device longevity.
 MVP®, or Managed Ventricular Pacing, available since 2004, allows doctors to dramatically reduce unnecessary pacing to the right
ventricle. The feature is included in all Protecta XT ICDs.
 Conexus® Wireless Telemetry allows patients to transmit device data to a physician’s clinic from virtually anywhere via the industry’s
largest remote monitoring system, the Medtronic CareLink® Network. CareLink serves more than 4,000 clinics and 500,000 patients
enrolled in 30 countries.

Implantable Defibrillator Impact

 Implantable defibrillators are designed to provide painless pacing or lifesaving shock therapy to stop life-threatening fast or irregular
heartbeats, also known as ventricular arrhythmias, which can lead to sudden cardiac death.
 Medtronic estimates more than 70,000 lives have been saved by implantable defibrillators over the past five years.
5

 ICDs are proven to be 98 percent effective in treating dangerous arrhythmias that can lead to sudden cardiac arrest. 6, 7

1
Volosin et. al. “Virtual ICD: A Model to Evaluate Shock Reduction Strategies.” Heart Rhythm.
Vol. 7, N. 5, May supplement 2010. (PO3-125).
2
Whellan DJ, Ousdigian KT, Al-Khatib SM, et. al. Combined heart failure diagnostics identify
patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF
Study. J Am Coll Cardiol, April 27,2010,55(17):1803-1810.
3
Hettrick DH, Sarkar S, Abraham WT, et al. Improved algorithm to detect worsening heart failure
via intrathoracic impedance monitoring in patients with implantable devices. ACC Scientific
Session, March 2010.
4
Wathen MS, et al. Circulation. 2004;110:2591-2596. Wathen MS, et al. Circulation.
2001;104:796-801.
5
Medtronic data on file. 2010.
6
DP Zipes, D Roberts, for the Pacemaker-Cardioverter-Defibrillator investigators. Results of the
International Study of the Implantable Pacemaker Cardioverter-Defibrillator: A Comparison of
Epicardial and Endocardial Lead Systems. Circulation. 1995;92:59-65.
7
Volosin et. al. “Virtual ICD: A Model to Evaluate Shock Reduction Strategies.” Heart Rhythm.
Vol. 7, N. 5, May supplement 2010. (PO3-125).

Brief Statement
Medtronic ICDs and CRT-ICDs
Medtronic Implantable Cardioverter Defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for
automated treatment of life-threatening ventricular arrhythmias. Medtronic Cardiac Resynchronization Therapy (CRT) ICDs are indicated for
ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and for the
reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic
despite stable, optimal medical therapy and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration.
Contraindications
Medtronic ICDs and CRT-ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes,
patients with incessant VT or VF, or patients who have a unipolar pacemaker. Medtronic ICDs are also contraindicated for patients whose
primary disorder is bradyarrhythmia.
Warnings and Precautions
Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid
sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue
damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over
the device. Additionally, for CRT-ICDs, certain programming and device operations may not provide cardiac resynchronization.
Potential Complications
Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation,
oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications
such as hematoma, infection, inflammation, and thrombosis.

See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and
potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website
at www.medtronic.com.
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Medtronic, Inc. 2013