Abbott
GALLANT™ AND ENTRANT™ ICDs & CRT-Ds
Available in all configurations to improve quality of life for patients at every stage of therapy.
Precision Shock Technology
Right Energy. Right Time. For greater first-shock success.
Timing is critical when shocking a patient out of Ventricular Fibrillation (VF). Precision Shock Technology delivers the right energy within the optimal time window for greater first-shock success. Energy delivered outside this response window is considered wasted.
Delivered Energy vs. Time
This section presents a comparison of delivered energy over time for different implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) manufacturers. The graph plots Delivered Energy (Joules) on the vertical axis against Shock Time (milliseconds) on the horizontal axis. The Abbott device demonstrates higher delivered energy earlier in the shock sequence compared to Medtronic, Boston Scientific, and Biotronik. A shaded region on the graph indicates the "Tissue Time Constant" range.
Manufacturers Compared:
- Abbott
- Medtronic
- Boston Scientific
- Biotronik
*Assumes standard 66.3 Ohm patient load at maximum rated shock energy. Efficiency is calculated as Delivered to Stored Energy Ratio. Graphs are simulated using publicly available data from Instructions for Use (IFUs), methods, and data on file. Simulated models present approximately ±6% variance on delivered energy. (Engineering Test Report 91111487 Rev. C)
Percentage of Effective Energy Delivered at 4 ms
This bar chart compares the percentage of effective energy delivered at 4 milliseconds by different manufacturers' devices. Abbott leads with 75% effective energy delivery, followed by Medtronic (71%), Boston Scientific (70%), and Biotronik (65%).
Manufacturer Comparison at 4 ms:
- Abbott: 75%
- Medtronic: 71%
- Boston Scientific: 70%
- Biotronik: 65%
Precision Shock Technology is engineered to optimize the energy delivery profile. Abbott devices are designed to deliver the highest voltage on the market and discharge energy earlier in the shock sequence.
Device Voltage Comparison
| Manufacturer | Voltage |
|---|---|
| Abbott | 894 V |
| Medtronic | 728 V |
| Boston Scientific | 728 V |
| Biotronik | 684V |
Improved Shock Efficacy Using Optimized Precision Shock Technology
Clinical data highlights the benefits of optimized Precision Shock Technology:
- 295 Patients Studied: Comparison of Optimized Precision Shock Technology versus standard "out-of-the-box" settings.
- 14% Improvement: Clinical data showed that patients programmed with optimized Precision Shock Technology achieved a significant improvement in first-shock success rates by 14%.
- 100% Success Rate: Programming patient-specific shock pulse widths with Precision Shock Technology resulted in a 100% success rate for first-shock conversions.
Learn more about Abbott's ICD & CRT-D Solutions.
References
- Improved ICD Shock Efficacy using Programmable Pulse Width. Michael Katcher, MD; Kevin Davis, BS; Nima Badie, PhD; Luke C. McSpadden, PhD; Ulrika Birgersdotter-Green, MD; Jacqueline Joza, MD; Robert Schaller, MD; Gabriel Mouchawar, PhD. Heart Rhythm Society Conference. April 24-27, 2025.
- Swerdlow C., Brewer J., Kass R., Kroll M. (1997). Application of models of defibrillation to human data: Implications for optimizing implantable defibrillator capacitance. Circulation 96(9), pgs. 2813-2822.. DOI: 10.1161/01.CIR.96.9.2813
- Ellenbogen K., Wilkoff, G., Kay G., Lau C. (2007). Clinical Cardiac Pacing, Defibrillation, and Resynchronization Therapy (3rd ed.). Elsevier Saunders; pg 542-547. ISBN-13: 978-1-4160-2536-8
- Kawata, U., Birgersdotter- Green, U. (2018). Ventricular Fibrillation and Defibrillation, Encyclopedia of Cardiovascular Research and Medicine. Elsevier, pgs 674-682. ISBN 9780128051542. DOI: 10.1016/B978-0-12-809657-4.99764-3
- Efimov, I., Kroll, M., Tchou, P. (2009). Cardiac Bioelectric Therapy. Springer, pgs. 468-472. ISBN 978-0-387-79403-7
- Kroll, M., Lehmann, M. (1996). Implantable Cardioverter Defibrillator Therapy. Kluwher Academic Publishers, pgs. 68 -69.
- Gold, M., Shorofsky S. (1997). Strength-duration relationship for human transvenous defibrillation. Circulation 96:3517-3520.
- Kroll, M., Swerdlow, C. (2007). Optimizing defibrillation waveforms for ICDs. Journal of Interv Card Electrophysiol 18:247-263. DOI 10.1007/s10840-007-9095-z
- Doshi, S., Pittaro, M., Reeves, M., Boyce, K., Payne, J., Kroll, M., Graumann, R., Oza, A., Val- Mejias, J. (2012). Efficacy of Tuned Waveforms Based on Different Membrane Time Constants on Defibrillation Thresholds: Primary Results from the POWER Trial. PACE Vol. 00. Pg. 8. DOI: 10.1111/j.1540-8159.2012.03500.x
- Abbott IFU (Gallant) (ARTEN600312644 A), Medtronic IFU (Cobalt™): (M029527C001), Boston Scientific IFU(Resonate™, Perciva™, Charisma™, Viglant™, and Momentum™):, Biotronik technical manual (Rivacor™) (439133, Rev. C)
Brief Summary
Rx Only
Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.
Intended Use
Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are intended for patients requiring treatment for life-threatening ventricular arrhythmias. They provide antitachycardia pacing and ventricular cardioversion/defibrillation. Additionally, these devices can manage chronic symptomatic bradyarrhythmia and various atrioventricular conduction abnormalities through sensing and pacing. CRT-D devices also synchronize the electrical activity of the right and left ventricles to improve heart function. The myMerlin Pulse™ mobile application facilitates remote monitoring of implanted Abbott Medical heart devices by transmitting data to healthcare providers.
Indications
ICD devices are indicated for patients who have survived cardiac arrest or are at high risk of Sudden Cardiac Death (SCD) due to Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF). Cardiac Resynchronization Therapy (CRT) devices are indicated to reduce symptoms in patients with congestive heart failure, a reduced left ventricular ejection fraction (LVEF), and a prolonged QRS duration. CRT-D devices are indicated for patients meeting CRT criteria who also have survived cardiac arrest or are at high risk of SCD due to VT or VF. Devices are typically implanted in a pectoral pocket.
The myMerlin Pulse™ mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices.
Contraindications
Contraindications for the pulse generator system include ventricular tachyarrhythmias caused by transient or correctable factors like drug toxicity, electrolyte imbalance, or acute myocardial infarction. The myMerlin Pulse™ mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices.
Adverse Events
Potential adverse events associated with the implantation of the pulse generator system include, but are not limited to: arrhythmia induction, bradycardia, cardiac or venous perforation, cardiac tamponade, cardiogenic shock, death, discomfort, embolism, endocarditis, erosion, exacerbation of heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), extrusion, fluid accumulation in the device pocket, formation of hematomas, cysts, or seromas, heart block, hemorrhage, hemothorax, hypersensitivity (including local tissue reaction or allergic reaction), infection, keloid formation, myocardial damage, nerve damage, occlusion/thrombus, pericardial effusion, pericarditis, pneumothorax, pulmonary edema, syncope, thrombosis, and valve damage. Procedural complications from subclavian venipuncture may include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage, and rarely, death. Psychological effects may include perceived pulsing, depression, dependency, fear of battery depletion or device malfunction, inappropriate shocks, or loss of pacing capability. Adverse device effects can arise from abnormal battery depletion, conductor fracture, device-programmer communication failure, elevated defibrillation/cardioversion thresholds, inability to defibrillate or pace, programmer or device malfunction, incomplete lead connection, inhibited or inappropriate therapy (shocks, ATP), interference from electrical/magnetic sources, intolerance to high-rate pacing, lead abrasion/fracture/insulation damage/migration, loss of functionality due to component failure, pulse generator migration, rise in DFT/pacing thresholds, exit block, energy shunting from paddles, or system failure due to radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include allergic reaction to contrast media, breakage or failure of implant instruments, prolonged exposure to fluoroscopic radiation, and renal failure from contrast media.
No potential adverse events have been identified with use of the myMerlin Pulse™ mobile application.
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