MARLBOROUGH, Mass., April 20, 2015 /PRNewswire/ -- Today the Journal of the American College of Cardiology published data confirming the long-term safety and efficacy of the Boston Scientific Corporation (NYSE: BSX) S-ICD System™ (subcutaneous implantable defibrillator) for patients at risk of sudden cardiac arrest.
The study, "Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-year Results from a Pooled Analysis of the IDE Study and EFFORTLESS Registry" was led by Dr. Martin Burke, professor of medicine at the University of Chicago. The analysis combined data from two large S-ICD studies to provide the most comprehensive look at S-ICD System patient outcomes to date.
The S-ICD System – which was approved by the Food & Drug Administration (FDA) in 2012 and which gained Category 1 CPT Codes in January – was shown to be highly effective, converting more than 98 percent of heart arrhythmias that can lead to sudden death. These data are comparable to efficacy outcomes found in transvenous ICD (TV-ICD) clinical trials (95-99%)1-4.
When assessing 889 patients with a total of 1,571 patient-years of follow-up, there were no lead failures and no systemic infections associated with the S-ICD System. The total rate of complications observed in this analysis was low relative to rates found in comparable TV-ICD studies5,6. The rate of cumulative complications increased by just one percentage point annually after the first year (9% at one year; 10% at two years; 11% at three years). Major acute complications related to the operation were lower than observed in studies with TV-ICD (2%[i] versus 3-5%)7,8.
"The S-ICD device sits just below the skin without the need for electrodes or leads to be placed into the heart and so it makes sense that we see decreased serious complications," said Dr. Burke. "By using the S-ICD System we can avoid the key risks that cause systemic or endovascular infections, which can add weeks to a hospital stay, incur tens of thousands of dollars in incremental hospital costs, and which are also associated with mortality for up to one-third of TV-ICD patients who acquire this type of infection."
The all-cause mortality rate for the S-ICD patients was 1.6 percent per year, comparing favorably to observed mortality rates in similar TV-ICD studies (2.5-5.5% per year)9-11.
This study combined data from the U.S. Investigational Device Exemption study that led to the device's approval by the FDA and also data from the EFFORTLESS registry, each with extended follow-up (average 22 months) relative to previously published reports on the S-ICD System.
Currently, the S-ICD System is covered nationally by Medicare, Aetna, Cigna and others, and regionally by numerous private and Medicaid plans, providing coverage for approximately 170 million individuals in the U.S.
The S-ICD System has been commercially available in Europe since 2009. For more information on the S-ICD system, please visit www.bostonscientific.com/sicd.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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Boston Scientific Corporation
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Boston Scientific Corporation
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[i] S-ICD complications included hematoma and lead/device mal-positioning/displacement
1Swerdlow CD, et al. The dilemma of ICD implant testing. Pacing Clin Electrophysiol 2007;30:675-700.
2Gold MR, et al. Efficacy and temporal stability of reduced safety margins for ventricular defibrillation: primary results from the Low Energy Safety Study (LESS). Circulation 2002;105:2043-2048.
3Cha YM, et al. Impact of shock energy and ventricular rhythm on the success of first shock therapy: the ALTITUDE first shock study. Heart Rhythm 2013;10:702-708.
4Kutyifa V, et al. Clinical impact, safety, and efficacy of single- versus dual-coil ICD leads in MADIT-CRT. J Cardiovasc Electrophysiol 2013;24:1246-1252.
5Kirkfeldt RE, et al. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J 2014;35:1186-1194.
6Ezzat VA, et al. A systematic review of ICD complications in randomised controlled trials versus registries: is our 'real-world' data an underestimation? Open Heart 2015;2:e000198.
7Peterson PN, et al. Association of single- vs dual-chamber ICDs with mortality, readmissions, and complications among patients receiving an ICD for primary prevention. JAMA 2013;309:2025-2034.
8van Rees JB, et al. Implantation-related complications of implantable cardioverter-defibrillators and cardiac resynchronization therapy devices: a systematic review of randomized clinical trials. J Am Coll Cardiol 2011;58:995-1000.
9Moss AJ, et al. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med 2012;367:2275-2283.
10Healey JS, et al. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet 2015;385:785-791.
11 van der Heijden AC, et al. The clinical course of patients with implantable defibrillators: Extended experience on clinical outcome, device replacements, and device-related complications. Heart Rhythm 2015.
SOURCE Boston Scientific Corporation