The Untouched study is slated to enroll a minimum of 2,015 patients with no documented, life-threatening arrhythmic event who are at risk of sudden cardiac death. The 18-month study will compare outcomes with the performance markers set out in the Madit-RIT trial of transvenous ICDs, Boston Scientific 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,” European Union principal investigator Dr. Lucas Boersma, of Holland’s St. Antonius Hospital, said in prepared remarks. “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.”
“In the published data to date, we have observed S-ICD devices demonstrate comparable inappropriate shock rates for arrhythmias to TV-ICDs,” added U.S. principal investigator Dr. Michael Gold of the Medical University of South Carolina, Charleston. “Ideally, this trial will demonstrate S-ICD devices can either meet or improve upon the inappropriate shock rates experiences with TV-ICDs in Madit-RIT within this large patient population.”
Boston Scientific said the Emblem S-ICD, which won CE Mark approval in the EU earlier this year and pre-market approval from the FDA in March, launched in Europe last month. The device hit the U.S. market earlier this month ahead of a full launch during the 3rd quarter, the company said.