Boston Scientific is planning to conduct an ‘UNTOUCHED study’ to find out the rate and the root cause of shocks observed in patients implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD).
The study is expected to help in prevention of sudden cardiac death where the patient suffers from severely reduced cardiac function (left ventricular ejection fraction </= 35 percent).
Boston Scientific claims that primary prevention patients do not have a history of life-threatening arrhythmic event but they stand a chance of having sudden cardiac arrest, which leads to death.
The group patient group represents the highest number of individuals in the US and Europe who have transvenous ICD (TV-ICDs) devices implanted.
The UNTOUCHED study will compare outcomes during an 18-month follow-up period to objective performance criteria that is found out through the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) study.
MADIT-RIT evaluated shock rates in 1500 patients who had got TV-ICD devices implanted
St. Antonius Hospital EU principal investigator Dr Lucas Boersma said: "The MADIT-RIT trial demonstrated that standardized programming using higher rate cutoffs and longer delays to therapy reduces the incidence of inappropriate shocks for TV-ICDs.
"The UNTOUCHED trial will examine the incidence of all-cause shocks when using the EMBLEM S-ICD System with standardized therapy settings similar to MADIT-RIT."
Boston Scientific’s S-ICD System has already been approved by the FDA and has stated selling in Europe and has been rolled out in the US.