Boston Scientific Corporation (NYSE:BSX) has indicated its intention of carrying a global study in the evaluation of the endurance of patients treated with the EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD) System. The study will be putting more emphasis on those above 65 years given they have a higher risk of sudden cardiac arrest (SCA). However, they must have an account of previous heart attacks, diabetes and reasonably reduced left ventricular ejection fraction.
The enrollment of patients
The first patient into the multicenter MADIT S-ICD trial of the system has already been enrolled. However, according to the principal investigator, Dr. Michael Giudici, the trial will enroll another 1,800 patients from 100 sites worldwide.
The principal investigator and research assistant professor of cardiology, Dr. Valentina Kutyifa outlines, “Our hypothesis is that the S-ICD device may reduce all-cause mortality in this high-risk cohort of cardiac patients with diabetes.”
It is worth nothing that there was a key consideration in designing the trial. Kutyifa explains that they were keen on reducing pointless patient barriers through the implantation of a defibrillator. Nonetheless, it is designed as one of the two clinical studies that will steer the company’s WIN-Her Initiative.
The EMBLEM MRI-S-ICD System has been accepted for parallel review
If approved, patients at risk of SCA will have a treatment option with the device. Furthermore it does not interfere with the heart and vasculature; instead, it will play a significant role in reducing the threat of some obstacles. The U.S. Food and Drug Administration (FDA) has already endorsed the system for a parallel review and so is the Centers for Medicare & Medicaid Services. There will be a concurrent review of the MADIT S-ICD trial data.
Senior VP and chief medical officer of Global Health Policy and Rhythm Management say that they excited about the new development because it will enhance the extensive applicability of the MADIT S-ICD trial results. In any case, their commitment is in having more patients benefit from the new technology.
In the meantime, Boston Scientifics’ stock closed at $24.81 witnessing an increase of $0.34 or 1.39%.