FDA Approval Of Subcutaneous Implantable Defibrillator For Patients At Risk Of Sudden Cardiac Arrest

The U.S. Food and Drug Administration has granted Boston Scientific Corporation regulatory approval for its S-ICD(R) System, the world's first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). Sudden cardiac arrest is an abrupt loss of heart function. Most episodes are caused by the rapid and/or chaotic activity of the heart known as ventricular tachycardia or ventricular fibrillation. Recent estimates show that approximately 850,000 people in the United States are at risk of SCA and indicated for an ICD device, but remain unprotected read more

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