SAN FRANCISCO and MARLBOROUGH, Mass., May 10, 2019 /PRNewswire/ -- Boston Scientific
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 Lucas V.A. Boersma, M.D., Ph.D., study principal investigator and electrophysiologist at St. Antonius Hospital, the Netherlands. "These acute outcomes also validate the advantages of the two-incision implant technique, which has continued to gain worldwide adoption in the last few years."
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 Kenneth Stein, M.D., senior vice president and chief medical officer, Global Health Policy and Rhythm Management, Boston Scientific. "We remain proud of the clinical success of the S-ICD System, which has now been implanted in nearly 60,000 patients worldwide, and we will continue to invest in clinical studies that advance our understanding of the role of the device in patients at risk of sudden cardiac death."
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.
About Boston Scientific Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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SOURCE Boston Scientific
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