Protecta^TM XT Cardiac Resynchronization Therapy Defibrillators (CRT-D)

References

1. Kadish A, Dyer A, Daubert JP, et al., for the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004;350:2151-2158.
2. Daubert JP, Zareba W, Cannom DS, et al., for the MADIT II Investigators. Inappropriate implantable cardioverter-defibrillator shocks in MADIT-II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol. 2008;5:1357-1365.
3. Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. September 4, 2008;359:1009-1017.
4. Mitka M. New study supports lifesaving benefits of implantable defibrillation devices. JAMA. 2009;302:134-135.
5. Sears SF JR, Todaro JF, Lewis TS, et al. Examining the psychosocial impact of implantable cardioverter defibrillators: a literature review. Clin Cardiol. 1999;22:481-489.
6. Sears SF Jr, Conti JB. Understanding implantable cardioverter defibrillator shocks and storms: medical and psychosocial considerations for research and clinical care. Clin Cardiol. 2003;26:107-111.
7. Irvine J, Dorian P, Baker B, et al. Quality of life in the Canadian Implantable Defibrillator Study (CIDS). Am Heart J. 2002;144:282-289.
8. Wathen MS, DeGroot PJ, Sweeney MO, et al, for the PainFREE RX II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators. Circulation. 2004;110:2591-2596.
9. Ahmad M, Bloomstein L, Roelke M, et al. Patients’ attitudes toward implantable defibrillator shocks. PACE. 2000;23:934-938.
10. Sweeney MO, Sherfesee L, DeGroot PJ, et al. Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010;7:353-360.

References

1. Volosin KJ, Exner DV, Wathen MS, Sherfesee L, Scinicariello A, Gillberg JM. Combining shock reduction strategies to enhance ICD therapy: A role for computer modeling. J Cardiovas Electrophysiol. Published online October 11, 2010.
2. Protecta Clinical Study, Medtronic data on file.

References

1. American Heart Association. Heart Disease and Stroke Statistics – 2010 Update.
2. American Heart Association. Heart Disease and Stroke Statistics – 2004 Update. Dallas, TX: American Heart Association. 2004.
3. Sackner-Bernstein J. What is heart failure and what are the treatment options? Complex questions. In: Hayes DL, Wang PJ, Sackner-Bernstein J, Asirvatham SJ, eds. Resynchronization and Defibrillation for Heart Failure: A Practical Approach. Oxford, England: Blackwell Publishing; 2004:1-2.
4. Small RS. Integrating device-based monitoring into clinical practice: insights from a large heart failure clinic. Am J Cardiol. May 21, 2007;99(10A):17G-22G.
5. Fonarow GC. How well are chronic heart failure patients being managed? Rev Cardiovasc Med. 2006;7(suppl 1):S3-11.
6. Friedman MM. Older adults’ symptoms and their duration before hospitalization for heart failure. Heart Lung 1997;26:169 –176.
7. Evangelista LS, Dracup K, Doering LV. Treatment-seeking delays in heart failure patients. J Heart Lung Transplant 2000;19:932–938.
8. Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA 1989;261: 884–888.
9. Vinson JM, Rich MW, Sperry JC, Shah AS, McNamera T. Early readmission of elderly patients with congestive heart failure. J Am Geriatr Soc 1990;38:1290 –1295.
10. Abraham WT. Superior performance of intrathoracic impedance-derived fluid index versus daily weight monitoring in heart failure patients. Results of the Fluid Accumulation Status Trial. Late Breaking Clinical Trials. J Card Fail. Vol. 15 No. 9 2009, p 813. (FAST).

References

1. Analysis from the German TEAM-Study, 2006. Medtronic Internal Data.

References

1.Tekmen, Mohac. “Worldwide Sales Memo 2012.” Medtronic DF4 System is designed to perform beyond the 1.5x safety factor for electrical isolation defined in ISO 27186. Medtronic data on file. January 26, 2012.
2. Himes, Adam. “Worldwide Sales Memo 2012.” The new DF4 lead has over 58% reduction in lead connector volume. Medtronic data on file. January 26, 2012.
3. Lulic, Thomas. “Worldwide Sales Memo 2012.” The DF4 Connector becomes more pliable in the body. Medtronic data on file. January 26, 2012.
9. Himes, Adam. “Worldwide Sales Memo 2012.” The lead connector underwent robust testing and analysis that included clinical measurements to replicate lead shapes for test inputs, and tests up to 2.5 million cycles. Medtronic data on file. January 26, 2012.

Brief Statement: Protecta™/Consulta®/Secura® CRT-D/DR ICDs and Sprint Quattro® 6947M Lead

Indications:
Protecta/Protecta XT, Secura, and Consulta implantable cardioverter defibrillators (ICDs) and CRT-D ICDs are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of lifethreatening ventricular arrhythmias. Protecta/Protecta XT and Consulta (CRT-D) ICDs are also indicated 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 ≤ 35% and a prolonged QRS duration. Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication.
The Sprint Quattro 6947M Lead is intended for single, long-term use in the right ventricle and has application for patients for whom ICDs are indicated. Additional Protecta/Protecta XT and Secura DR System Notes: The use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias.

• The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 17%, and in terminating device classified atrial fibrillation (AF) was found to be 16.8%, in the VT/AT patient population studied.
• The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in terminating device classified atrial fibrillation (AF) was found to 18.2% in the AF-only patient population studied. Additional Protecta XT and Secura DR System Notes: The ICD features of the device function the same as other approved Medtronic market-released ICDs.
• Due to the addition of the OptiVol® diagnostic feature, the device indications are limited to the NYHA Functional Class II/III heart failure patients who are indicated for an ICD.
• The clinical value of the OptiVol fluid monitoring diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart failure.

Contraindications:
Protecta/Protecta XT, Secura and Consulta DR and CRT-ICDs are contraindicated for patients experiencing tachyarrhythmias with transient or reversible causes including, but not limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, or sepsis. The devices are also contraindicated for patients who have a unipolar pacemaker implanted, patients with incessant VT or VF, or patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF. The Sprint Quattro 6947M Lead is contraindicated for ventricular use in patients with tricuspid valvular disease or a tricuspid mechanical heart valve, for patients with transient ventricular tachyarrhythmias due to reversible causes (drug intoxication, electrolyte imbalance, sepsis, hypoxia) or other factors (myocardial infarction, electric shock) or for sole use of detection and treatment of atrial arrhythmias. The lead is also contraindicated in patients for whom a single dose of 1.0 mg of dexamethasone acetate and/or dexamethasone sodium phosphate may be contraindicated.

Warnings and Precautions:
ICDs: 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. Leads: People with metal implants such as pacemakers, ICDs, and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, or the need to reprogram or replace the device.

Potential Complications:
Potential complications include, but are not limited to, acceleration of ventricular tachycardia, air embolism, bleeding, body rejection phenomena, which includes local tissue reaction, cardiac dissection, cardiac perforation, cardiac tamponade, chronic nerve damage, constrictive pericarditis, death, device migration, endocarditis, erosion, excessive fibrotic tissue growth, extrusion, fibrillation or other arrhythmias, fluid accumulation, formation of hematomas/seromas or cysts, heart block, heart wall or vein wall rupture, hemothorax, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgement, mortality due to inability to deliver therapy, muscle and/or nerve stimulation, myocardial damage, myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, poor connection of the lead to the device, which may lead to oversensing, undersensing, or a loss of therapy, threshold elevation, thrombosis, thrombotic embolism, tissue necrosis, valve damage (particularly in fragile hearts), venous occlusion, venous perforation, lead insulation failure or conductor or electrode fracture. See the device manual 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.

Caution: Federal law (USA ) restricts these devices to sale by or on the order of a physician.
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