Boston Scientific begins new study of Emblem S-ICD system

Boston Scientific has announced the initiation of a new global study to assess its Emblem subcutaneous implantable defibrillator (S-ICD) system in primary prevention patients with low ejection fraction.

The study will evaluate the rate and causes of shocks for patients implanted with the device. Primary prevention patients do not have a previously documented life-threatening arrhythmic event, but are at risk of sudden cardiac death and thereby indicated to receive an implantable defibrillator.

Additionally, the UNTOUCHED study will compare outcomes during an 18-month follow-up period to objective performance criteria derived from the previous Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) study.

The MADIT-RIT study evaluated shock rates in 1,500 patients implanted with transvenous ICD devices, and is one of the largest randomised trials to assess shock reduction strategies for TV-ICD devices.

Dr Lucas Boersma, EU principal investigator and electrophysiologist at St Antonius Hospital in the Netherlands, said: "The UNTOUCHED trial will examine the incidence of all-cause shocks when using the Emblem S-ICD system with standardised therapy settings, similar to MADIT-RIT."

Last week, the company announced new clinical data showing the pain relief benefits offered by its Precision Spectra spinal cord stimulator system.