News | Implantable Cardioverter Defibrillator (ICD) | May 13, 2019

Emblem Subcutaneous ICD Safe and Effective for Majority of Patients

UNTOUCHED study shows S-ICD has low complication rate and high conversion efficacy in patients with low LVEF

Emblem Subcutaneous ICD Safe and Effective for Majority of Patients

May 13, 2019 — Boston Scientific announced acute results from the UNTOUCHED study evaluating safety and efficacy of the Emblem subcutaneous implantable defibrillator (S-ICD) system for primary prevention of sudden cardiac death specifically in patients with a left ventricular ejection fraction (LVEF) ≤35 percent. This is the most common population to be indicated for ICD therapy. The results demonstrated S-ICD therapy had a complication-free rate of 95.8 percent at 30 days post-procedure and high conversion efficacy (99.2 percent) of induced ventricular fibrillation, rates comparable to those seen in previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies.

The data were presented during a late-breaking clinical trial at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions, May 8-11 in San Francisco. The analysis was also published online in the Heart Rhythm Journal.[1]

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 percent) 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."

Watch the VIDEO: Overview of Subcutaneous ICD Technology, an interview with Boersma.

The global, prospective, non-randomized study evaluated data from 1,116 patients with a low LVEF, the majority of whom (54 percent) had ischemic heart disease.

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.  

Read the article "Subcutaneous ICD System Shows Positive Outcomes in Largest Real-world Study"

For more information: www.bostonscientific.com

 

All the HRS 2019 late-breaking studies 

Link to other HRS 2019 news

 

 

Reference

1. Boersma L.V., El-Chami M.F., Bongiorni M.G., et al. Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results. Heart Rhythm Journal, published online May 10, 2019. https://doi.org/10.1016/j.hrthm.2019.04.048

 
 

Related Content

News | Implantable Cardioverter Defibrillator (ICD)

Sept. 2, 2024 – Medtronic recently shared long-term results from the global Extravascular Implantable Cardioverter ...

Home September 05, 2024
Home
News | Implantable Cardioverter Defibrillator (ICD)

February 12, 2024 — BIOTRONIK, a leader in implantable medical device technology, announced today they will solely ...

Home February 12, 2024
Home
News | Implantable Cardioverter Defibrillator (ICD)

October 23, 2023 — Medtronic plc, a global leader in healthcare technology, has received U.S. Food and Drug ...

Home October 23, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

August 28, 2023 — Is the routine implantation of an implantable cardioverter defibrillator (ICD) in myocardial ...

Home August 28, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

August 28, 2023 — Upgrade to cardiac resynchronization therapy with a defibrillator (CRT-D) reduces morbidity and ...

Home August 28, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

July 18, 2023 — The U.S. Food and Drug Administration (FDA) has issued a Class I recall on the Medtronic ICDs and CRT-Ds ...

Home July 18, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

March 7, 2023 — Ninety-five percent of athletes with a diagnosed and treated genetic heart disease experienced no ...

Home March 07, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

February 17, 2023 — Medtronic plc has received CE (Conformité Européenne) Mark for the Aurora EV-ICD MRI SureScan ...

Home February 17, 2023
Home
News | Implantable Cardioverter Defibrillator (ICD)

August 29, 2022 — Medtronic plc announced that its investigational EV ICD System – a first-of-its-kind defibrillator ...

Home August 29, 2022
Home
Subscribe Now