Boston Scientific’s Emblem subcutaneous implantable defibrillator (S-ICD) system has achieved a complication-free rate of 95.8% at the Untouched study.
The data from the trial showed that S-ICD therapy had a complication-free rate of 95.8% at 30 days post-procedure and high conversion efficacy (99.2%) of induced ventricular fibrillation, rates compared against previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies.
Untouched study has been designed to assess safety and efficacy of the Emblem S-ICD system for primary prevention of sudden cardiac death specifically in patients with a left ventricular ejection fraction (LVEF) ≤35%, the common population to be indicated for ICD therapy.
The authors of the study also assessed procedure techniques and 30-day outcomes in patients implanted with the Emblem-ICD system and observed that the majority (69%) of procedure have been performed using a two-incision technique.
The two-incision technique data showed a mean implant time of 55.8 minutes, which was eight minutes faster than the mean 63.8 minutes for procedures that leveraged a three-incision implant technique, with comparable complication and conversion success rates.
Untouched study principal investigator Dr Lucas Boersma said: “We found that the complication rate within this primary prevention population was as low as in prior S-ICD registries, despite the patients having much lower LVEF, more hypertension, and diabetes – underscoring that sicker patients do well with this device for the prevention of sudden death.”
Untouched is a global, prospective and non-randomized study, which assessed data from 1,116 patients with a low LVEF, the majority of whom (54%) had ischemic heart disease.
The study’s final results, including an analysis comparing inappropriate shock rates of the S-ICD to rates found in previous TV-ICD studies, will be revealed after 18-months of patient follow-up.
Boston Scientific global health policy and rhythm management chief medical officer and senior vice president Dr Kenneth Stein said: “The data presented today reiterate the value of the EMBLEM S-ICD System for a broad group of ICD-indicated patients, enabling them to avoid the long-term complications associated with TV-ICD leads.”