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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:
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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
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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
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.
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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
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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
CONTACT:
Wendy Dougherty
(763) 526-2853
[email protected]
¹Volosin 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.
3Hettrick 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.
4Wathen MS, et al. Circulation. 2004;110:2591-2596. Wathen MS, et al. Circulation. 2001;104:796-801.
5Medtronic data on file. 2010.
6DP 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.
7Volosin 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 lifethreatening 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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