I agree with bb252 that it is definitely a Class III device as it poses high risk to the patients. But this device is generally used under the condition where the patient has a weak heart and implanting ICD is not an option and is likely to benefit from its usage. Apart from that it overcomes some of the limitations of ICD’s with respect to magnetic and electromagnetic radiations. So in my opinion, after discussing the potential benefits and risks with the physician associated with this device, it is worth giving a try for the patients who are at high risk for sudden cardiac arrest.