Feature | April 21, 2015

Long-Term Data Underscore Safety, Efficacy of Boston Scientific’s S-ICD System

Major acute complications reduced when compared to transvenous ICD devices

Boston Scientific, S-ICD, long-term data, TV-ICD, trial

April 21, 2015 — The Journal of the American College of Cardiology published data confirming the long-term safety and efficacy of the Boston Scientific Corp. 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 Martin Burke, M.D., 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 U.S. Food & Drug Administration (FDA) in 2012 and gained Category 1 CPT Codes in January 2015 – 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 percent).

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 studies. The rate of cumulative complications increased by just one percentage point annually after the first year (9 percent at one year; 10 percent at two years; 11 percent at three years). Major acute complications related to the operation were lower than observed in studies with TV-ICD (2 percent[i] versus 3-5 percent).   

"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 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 percent per year).

This study combined data from the U.S. Investigational Device Exemption study that led to the device's approval by the FDA plus data from the EFFORTLESS registry, each with extended follow-up (average 22 months) relative to previously published reports on the S-ICD System. 

For more information: www.bostonscientific.com

Related Content

Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
New Study Focuses on Protein Responsible For Increased Heart Disease Risk
News | Cardiac Diagnostics| August 03, 2017
August 3, 2017 — A study to reduce the strongest inherited...
Overlay Init