The PMA included data from a Pivotal investigational device exemption (IDE) clinical study, enrolling 330-patient,which assessed the safety and efficacy of the S-ICD System in patients at risk of sudden cardiac arrest (SCA).
The S-ICD System is a subcutaneous implantable defibrillator which detects highly accelerated and disorganized heart rhythms caused by ventricular arrhythmias.
The S-ICD System delivers an 80 Joule shock to restore the heart’s normal rhythm, when abnormal arrhythmias are detected.
Cameron Health president and CEO Kevin Hykes said they look forward to work closely with the FDA through the review process to make this technology available to more patients at risk of SCA.
