|Late-Breaking Trial Data Highlight Continued Clinical Success Of Boston Scientific EMBLEM™ S-ICD System|
The UNTOUCHED study authors also reviewed procedure techniques and 30-day outcomes in patients implanted with the EMBLEM S-ICD System and found that the majority (69%) of procedures were performed using a two-incision technique. The two-incision technique data demonstrated a mean implant time of 55.8 minutes, which was 8 minutes faster than the mean 63.8 minutes for procedures that leveraged a three-incision implant technique, with comparable complication and conversion success rates.
"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," said
The global, prospective, non-randomized study evaluated data from 1,116 patients with a low LVEF, the majority of whom (54%) had ischemic heart disease.
"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," said
The final results of the UNTOUCHED study, including an analysis comparing inappropriate shock rates of the S-ICD to rates found in previous TV-ICD studies, will be reported after 18-months of patient follow-up.
For more information on the EMBLEM S-ICD System visit www.sicdsystem.com.
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