Cameron Health has announced that it has completed enrolment in its clinical study of the Subcutaneous Implantable Defibrillator (S-ICD) system.
The S-ICD system detects highly accelerated and disorganised heart rhythms and provides a jolt of electricity to restore the heart’s normal rhythm and prevent sudden cardiac arrest.
The study enrolled 330 patients from centres such as Ohio State University, the University of Chicago, Emory University, Sentara Heart Hospital and Auckland City Hospital.
The data from the study has primary clinical endpoints of arrhythmia conversion efficacy and complication-free rate at six months for qualified patients.
Cameron plans to submit the data to the US Food and Drug Administration in late 2011, to request marketing approval for the S-ICD System in the US.
Ohio State University Cardiovascular Medicine associate professor Dr Raul Weiss said the S-ICD System will be a viable treatment option for patients at risk of sudden cardiac arrest.