Boston Scientific (NYSE:BSX) yesterday touted a study published in the Journal of the American College of Cardiology showing the long-term safety and effectiveness of its S-ICD "leadless" defibrillator.
The study pooled 6-month to 1-year data from a pair of Boston Scientific-funded clinical trials, the S-ICD investigational device exemption trial and the Effortless post-market trial.
The JACC study followed 882 patients implanted with the S-ICD device, which Boston acquired when it bought Cameron Health for $1.35 billion in 2012, for 651 ± 345 days. There were 111 spontaneous ventricular tachyarrhythmia/ventricular fibrillation events treated in 59 patients, 100 of which (90.1%) were ended with 1 shock and 109 (98.2%) of which were ended within the 5 available shocks, according to the study.
The estimated 3-year inappropriate shock rate was 13.1%. Estimated 3-year, all-cause mortality was 4.7% (95% confidence interval: 0.9% to 8.5%), with 26 deaths (2.9%). Device-related complications cropped up in 11.1% of patients at 3 years. There were no electrode failures and no S-ICD–related endocarditis or bacteremia. Three devices (0.3%) were replaced for right ventricular pacing, according to the study.
The researchers, all of whom reported receiving support from Boston Scientific, concluded that the S-ICD "demonstrated high efficacy" for VT/VF, with complications and inappropriate shock rates "reduced consistently with strategic programming and as operator experience increased," according to the JACC study.
"These data provide further evidence for the safety and efficacy of the S-ICD," they wrote.
"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," lead author Dr. Martin Burke of the University of Chicago said in prepared remarks. "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."
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