According to Cameron Health, the S-ICD System detects highly accelerated and disorganized heart rhythms and provides a jolt of electricity (or shock) to restore the heart’s normal rhythm and prevent SCA.
Clinical investigators enrolled 330 patients at risk for sudden cardiac arrest (SCA) at 33 centers in the US, Europe and New Zealand.
The primary clinical endpoints are arrhythmia conversion efficacy and complication-free rate at six months for qualified patients.
The top 5 enrolling centers in the S-ICD System pivotal study were The Ohio State University, University of Chicago, Emory University, Sentara Heart Hospital and Auckland City Hospital.
Cameron Health plans to submit data from this pivotal study to the US Food and Drug Administration in late 2011.
The S-ICD System received CE mark in Europe in 2009.
The University of Chicago Heart Rhythm Center director Martin Burke said having the option to implant an ICD that does not require placement of leads directly in the heart would be an important new alternative for countless patients.
