US-based Boston Scientific has started a new clinical trial to investigate its EMBLEM MRI subcutaneous implantable defibrillator (S-ICD) system in diabetes patients who have previously experienced heart attacks.
The EMBLEM MRI S-ICD system is considered to be a treatment option for sudden cardiac arrest (SCA) risk patients as it does not disturb the heart and vasculature, minimising the possibility of certain complications encountered when using transvenous implantable cardioverter defibrillators.
The device does not require intracardiac leads, which is considered vital for diabetes patients who are vulnerable to infection and vascular access.
The multicentre automatic defibrillator implantation trial with subcutaneous implantable cardioverter defibrillator (MADIT S-ICD) will include 1,800 patients, aged 65 and above, with a history of diabetes, heart attacks, and moderately reduced left ventricular ejection fraction.
The main objective of the prospective, randomised trial is to determine the system's ability to improve survival compared to patients undergoing medical therapy.
Boston Scientific global health policy and rhythm management senior vice-president and chief medical officer Kenneth Stein said: "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 MADIT S-ICD trial results by increasing the enrolment of women in this study.
"Moreover, the trial emphasises our continued commitment to expanding access to all patients who may benefit from this proven technology."
The MADIT S-ICD trial is a part of Boston Scientific's WIN-Her Initiative that aims at increasing the recruitment of women in clinical trials.
Image: EMBLEM MRI S-ICD system. Photo: courtesy of Boston Scientific.