Boston Scientific recently announced that it is launching a worldwide study for its EMBLEM™ MRI Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) device. According to the press release, a multicenter trail of the device will focus on a group of patients who are above 65 years old with a history of prior heart attack, diabetes, and moderately reduced left ventricular ejection fraction, considered to be at higher risk of sudden cardiac arrest but unsuitable for implantable cardiac defibrillators. The study, according to Boston Scientific, is designed to evaluate whether the company’s EMBLEM MRI S-ICD System improves the survival rate in the target group of patients in comparison to patients continuing with their present treatment. Boston Scientific indicates that it is also seeking parallel approvals for a new indication from the FDA and the Center for Medicare & Medicaid Services for use of the device in treating the target group of patients.
Commenting on the study, Senior VP and Chief Medical Officer of Global Health Policy and Rhythm Management Dr. Kenneth Stein, stated:
“In addition to the knowledge we hope to gain from this population of patients with diabetes, we are excited for the opportunity to improve the broad applicability of the [multicenter] trial results by increasing the enrollment of women in this study. Moreover, the trial emphasizes our continued commitment to expanding access to all patients who may benefit from this proven technology.”
Dr. Valentina Kutyifa, principal investigator and research assistant professor of cardiology at the University of Rochester Medical Center, also stated:
“Our hypothesis is that the S-ICD device may reduce all-cause mortality in this high-risk cohort of cardiac patients with diabetes. The value of eliminating unnecessary patient complications by implanting a defibrillator which does not require intracardiac leads was an important factor in our decision to utilize the S-ICD device when designing this trial.”
Boston Scientific previously reported acquiring the S-ICD technology from Cameron Health in 2012.