Boston Scientific points us at a new publication that details registry data relating to the real world performance of the company’s S-ICD (Subcutaneous Implantable Cardioverter/Defibrillator) and finds the device does the job.
Real-world data on the Boston Scientific Corporation S-ICD System are highlighted online this week in the European Heart Journal. The interim analysis of the ongoing EFFORTLESS S-ICD registry, which evaluated 456 patients with a mean follow-up of 558 days, is the first real world study to date and confirms the clinical benefits of the S-ICD System in a broad range of patients at risk of sudden cardiac arrest. As the world’s least invasive implantable defibrillator, the S-ICD System provides protection for patients at risk of sudden cardiac arrest without touching the heart.
The EFFORTLESS registry is a post-market, observational, non-randomized study currently enrolling patients in seven countries, comprised of the Czech Republic, Denmark, Germany, Italy, the Netherlands, New Zealand and the United Kingdom. The registry is expected to enroll 1,000 patients and generate five years of follow-up data.
Interim results highlight a 100 percent conversion of spontaneous ventricular tachyarrhythmias, 99.7 percent conversion of acute ventricular tachyarrhythmias, 6.4 percent inappropriate therapy rate with the use of dual zone programming and 180- and 360-day complication-free rates of 94 percent
“This data set is important as it is the first long-term real world experience demonstrating safe and effective performance of the S-ICD System,” said Pier Liambase, Consultant Electrophysiologist at the Heart Hospital in London, England and lead author of the publication. “This should further establish the S-ICD System as a worthwhile option for a considerable portion of the ICD indicated population that is eligible for the S-ICD System.”
“The EFFORTLESS registry publication provides even more supportive evidence for this innovative therapy. These long-term results in a large patient cohort are comparable to similar data for transvenous ICDs and should help physicians as they decide which patients are the best candidates for the S-ICD System,” said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific.
Source: Boston Scientific Corporation, PR Newswire