Cameron Health has published S-ICD System study results online in the New England Journal of Medicine (NEJM), highlighting the development and potential benefits of the minimally invasive, subcutaneous implantable cardioverter defibrillator (ICD), for the treatment of sudden cardiac arrest (SCA).
Cameron Health said that in the studies, the S-ICD detected 100% of induced and spontaneous episodes of irregular heart rhythms. This publication represents nine years of development and clinical work with 17 medical centers in seven countries.
Cameron Health claimed that the S-ICD System’s implantation is entirely subcutaneous, eliminating the need for lead placement in or on the heart and simplifying the surgery by eliminating the need for imaging equipment. Transvenous ICD’s require placement of at least one lead in or on the heart.
Reportedly, most frequently, these leads are threaded through a vein and placed inside the heart, allowing for sensing of the heart’s rhythm and delivery of a life-saving electric shock when a harmful arrhythmia is detected. The surgical placement and ongoing presence of these transvenous leads within the patient’s heart are associated with a proportion of the complications related to this therapy.
The NEJM publication highlights four studies of the S-ICD System. Two short-term trials designed to identify a suitable device configuration and assess energy requirements were followed by two longer-term trials designed to assess the efficacy of the S-ICD System in detecting and treating ventricular fibrillation and ventricular tachyarrhythmias.
Results of the longer-term studies include 100% detection of induced arrhythmias and 98% conversion success for patients implanted with the S-ICD System. In addition, ventricular tachyarrhythmias were detected and treated in 100% of 12 spontaneous episodes.
Gust Bardy, MD of the Seattle Institute for Cardiac Research, lead author of the NEJM paper and co-founder of Cameron Health, said: “Transvenous implantable cardioverter defibrillators have proven to be an effective therapy for treating sudden cardiac arrest. As with any medical technology, however, there is room for improvement.
“These studies suggest that the S-ICD System is a viable alternative that may overcome some of the problems associated with transvenous ICDs in certain patients. The findings suggest that physicians now have an important new option to consider when evaluating patients for defibrillator therapy, and one that may reduce the barriers to adoption of this life-saving therapy.”
Kevin Hykes, president and CEO of Cameron Health, said: “Cameron Health’s goal in developing the S-ICD System was to improve upon current ICD therapy by reducing the complications associated with transvenous leads, as well as to simplify implantation, programming and follow-up.
“The publication of these data is a clear acknowledgement of the important pioneering contributions made by the clinical investigators.”